12,433 Clinical Data Managers jobs in the United States
Clinical Research Coordinator III, Clinical Trials
Posted today
Job Viewed
Job Description
Clinical Research Coordinator III supports participant recruitment, study visits (consenting, investigational product administration), protocol compliance, lab processing, inventory management, and sponsor collaboration. Dedicated to quality improvement, SOP review, and process standardization to enhance clinical trial infrastructure and ensure operational excellence.
Job Summary:
Collects data for clinical trials research, independently. Prepares and/or supports the submission of study documentation to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of standard and non-standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions, with limited guidance. Learns about providing input on implementing budgeting components for internally funded standard and non-standard projects. Drafts and/or prepares and submits clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.
Essential Responsibilities:
+ Pursues effective relationships with others by proactively providing resources, information, advice, and expertise with coworkers and members. Listens to, seeks, and addresses performance feedback; provides mentoring to team members. Pursues self-development; creates plans and takes action to capitalize on strengths and develop weaknesses; influences others through technical explanations and examples. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; helps others adapt to new tasks and processes. Supports and responds to the needs of others to support a business outcome.
+ Completes work assignments autonomously by applying up-to-date expertise in subject area to generate creative solutions; ensures all procedures and policies are followed; leverages an understanding of data and resources to support projects or initiatives. Collaborates cross-functionally to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports, identifies, and monitors priorities, deadlines, and expectations. Identifies, speaks up, and implements ways to address improvement opportunities for team.
+ Works on budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard and nonstandard projects.
+ Conducts clinical research by: independently collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments); leveraging a comprehensive foundational knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging a comprehensive foundational knowledge of clinical trials, studies, and interventions at the site-level; independently contributing to the development of standard and nonstandard clinical research protocols and other processes of clinical trials; preparing and/or supporting the submission of study documentation to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing standard and non-standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard and non-standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).
+ Ensures research compliance by: independently drafting and/or preparing and submitting clinical trial applications in compliance and consistency with all applicable federal, state, and local regulations, and reviewing and providing input on KP compliance policies and procedures; identifying compliance and/or quality issues and assisting in the development of corrective action plans, escalating as necessary; identifying opportunities to update compliance-monitoring/audit systems and documentation; utilizing standard approaches to analyze risk-management data and making recommendations to mitigate potential risk; independently implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging comprehensive research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.
+ Maintains internal and external effective working relationships by: leveraging a comprehensive foundational knowledge of how to partner with research stakeholders and investigators within and across units to contribute to research projects; independently communicating with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions with limited guidance.
+ Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) in a timely and accurate manner; assisting with the development and/or implementation of standard and nonstandard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a comprehensive foundational knowledge of how to monitor and audit Clinical Trials as well as documenting findings.
Minimum Qualifications:
+ Bachelors degree in Science, Public Health, Health Care Administration, or related field AND minimum two (2) years of experience in clinical research or a directly related field OR Minimum five (5) years of experience in clinical research or a directly related field.
Additional Requirements:
+ Knowledge, Skills, and Abilities (KSAs): Ethical Conduct; Clinical Research Quality; Innovative Mindset; Data Quality; Business Relationship Management; Managing Diverse Relationships; Stakeholder Management; Project Management Tools; Quality Assurance Process; Quantitative Research Methods; Survey Methodology; The Scientific Method; Computer Literacy; Accountability; Adaptability; Autonomy; Organizational Skills; Compliance; Clinical Research; Laboratory Procedures; Laboratory Equipment; Project Management; Experimental Design
COMPANY: KAISER
TITLE: Clinical Research Coordinator III, Clinical Trials
LOCATION: Duluth, Georgia
REQNUMBER:
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.
Clinical Research Specialist - Cancer Clinical Trials
Posted 8 days ago
Job Viewed
Job Description
**Additional information:**
The successful candidate must possess strong analytical and problem-solving skills, as well as the proven ability to build rapport and foster communication with study participants and team members.
**PEOPLE ESSENTIAL FUNCTIONS**
+ Supports the inter-professional team of clinical research investigators, nurses and coordinators. Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one other to achieve optimal department results.
+ Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.
**SERVICE ESSENTIAL FUNCTIONS**
+ Performs clinical research support functions as assigned by the clinical trial manager including but not limited to informed consent for non-interventional studies, data abstraction and recording in CRFs.
+ Makes phone calls to study patients for appointment reminders and follow-up.
+ Transports blood and tissue samples. Processes and packages lab samples for shipping to sponsor or storage at site per the study manual of operations.
**QUALITY/SAFETY ESSENTIAL FUNCTIONS**
+ Completes required case report forms and resolves queries. Ensures accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing.
+ Assists Clinical Trial Manager in identifying opportunities research workflow process improvement, providing recommendations, and contributes to meeting department and hospital targets for quality and safety.
**FINANCE ESSENTIAL FUNCTIONS**
+ Assures study conduct meets appropriate IRB, FDA, ICH and agency guidelines.
+ Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.
**GROWTH/INNOVATION ESSENTIAL FUNCTIONS**
+ Assist in simple data analysis, with development of training materials for data reports, systems and collection and report generation.
+ Leads and identifies opportunities for performance improvement. Supports change initiatives and adapts to unexpected changes.
+ Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
**EDUCATION**
+ Bachelor's degree in a related field
+ Bachelor's Degree in a Health-Science related field preferred
**WORK EXPERIENCE**
+ One year experience in healthcare setting preferred
+ Research setting preferred
**LICENSES AND CERTIFICATIONS - REQUIRED**
+ N/A
**KNOWLEDGE, SKILLS, AND ABILITIES**
+ Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
+ Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
+ Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
+ Exhibits good listening skills
+ Ability to work independently and analyze and solve problems
+ Demonstrates the ability to manage clinical and interpersonal situations
+ Able to prioritize tasks and manage multiple projects
+ Self-motivated with the ability to think critically and work independently
**SUPPLEMENTAL REQUIREMENTS**
**WORK ATTIRE**
+ Uniform No
+ Scrubs Yes
+ Business professional Yes
+ Other (department approved) No
**ON-CALL***
_*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below._
+ On Call* No
**TRAVEL***
_**Travel specifications may vary by department**_
+ May require travel within the Houston Metropolitan area Yes
+ May require travel outside Houston Metropolitan area No
**Company Profile:**
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.
Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.
Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.
Houston Methodist is an Equal Opportunity Employer.
Clinical Research Coordinator - Medicine Clinical Trials Office
Posted 3 days ago
Job Viewed
Job Description
The Clinical Research Coordinator is an entry human subjects researcher, responsible for conducting and assisting in clinical research studies under the supervision of the Principal Investigator or senior clinical research staff. This individual obtains informed consent, collects, maintains and organizes study information. Assists in the preparation and submission of grant applications and documents (e.g., Institutional Review Board, Grants and Contracts Office).
**Qualifications**
+ Bachelors degree in science or related field preferred or a combination of relevant research experience and education
+ 0-2 years of research/human subjects experience
**Responsibilities**
+ Conducts routine and standardized human subjects research using appropriate research or interview techniques specific to subject matter of the research project, under direct supervision of the Principal Investigator or senior clinical research staff.
+ Assists in the activities related to clinical research including, but not limited to: obtaining informed consent, screening participants for eligibility, registering patients with sponsoring agencies, administering questionnaires and answering telephone calls.
+ Assists in the collection, analysis and review of experimental data for publication and presentation.
+ Maintains source documents and subject files in accordance with Mount Sinai policies and procedures. Ensures accurate, confidential and complete compilation of data.
+ May secure and ship clinical specimens as required by the protocol.
+ May assist in the preparation for regulatory agency site visits.
+ Performs other related duties
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $16.5 - $ Hourly. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Clinical Research Consent Writer - Clinical Trials Start-Up
Posted 2 days ago
Job Viewed
Job Description
The primary purpose of the Clinical Research Consent Writer is to edit all informed consent documents attached to clinical/PBHSR/laboratory protocols submitted by MD Anderson faculty to the Office of Human Subjects Protections to maintain compliance with federal regulations and ensure the protection of human research subjects. The Clinical Research Consent Writer is responsible for editing informed consent documents to a sixth- to eighth-grade reading level, while remaining faithful to the meaning intended by the Principal Investigator and in compliance with federal regulations. Reorganization of the variable sections of the consent document is required to improve clarity, consistency, flow, and readability.
*The ideal candidate will have regulatory and editing experience, along with prior medical writing experience. Research certification preferred.*
The hours for this position are Monday - Friday, 8am-5pm (Central Standard Time)
The Clinical Trials Start-up teams work with the departments to provide support for study submissions.
These teams review new protocol submissions for document verification, write or edit the informed consents, and provide ongoing support with the Protocol Navigation team through activation. In addition, these groups can perform start-up regulatory functions for clinical department and also manage submissions to Harris Health.
*KEY FUNCTIONS*
Informed Consent Editing (80%)
Edit of all informed consent documents attached to clinical/PBHSR/laboratory protocols submitted by MD Anderson faculty to the Human Subjects Protection using correct grammar and punctuation.
Activation Timelines (10%)
Improve study activation timelines by increasing cross training and collaboration amongst central offices and research departments to streamline processes and create efficiencies.
Data Integrity (10%)
Ensure OHSP data integrity by performing accurate and consistent data entry into the relevant databases in the electronic system based on applicable job functions.
Success will be measured through fewer than 20% of contingencies being based on missing federal data elements in informed consents submitted to the IRB.
* MD Anderson offers our employees: *
* Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week.
* Group Dental, Vision, Life, AD&D and Disability coverage.
* Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals.
* Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs.
* Tuition Assistance Program after six months of service.
* Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans.
* Employer paid life, AD&D and an illness-related reduced salary pay program.
* Extensive wellness, recognition, fitness, employee health programs and employee resource groups.
* Opportunities for professional growth through Career Development Center and Mentoring programs.
*EDUCATION*
Required:
Bachelor's degree in a related field.
*EXPERIENCE*
Required:
Two years of regulatory or editing experience.
Preferred:
Prior Experience in medical writing
*CERTIFICATION*
Preferred:
Research certification (CCRP, CCRC, RAP, CIP)
The University of Texas MD Anderson Cancer Center offers excellent tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law. Information
* Requisition ID:
* Employment Status: Full-Time
* Employee Status: Regular
* Work Week: Day/Evening
* Minimum Salary: US Dollar (USD) 68,500
* Midpoint Salary: US Dollar (USD) 85,500
* Maximum Salary : US Dollar (USD) 102,500
* FLSA: exempt and not eligible for overtime pay
* Fund Type: Soft
* Work Location: Remote
* Pivotal Position: No
* Referral Bonus Available?: Yes
* Relocation Assistance Available?: No
#LI-Remote
Clinical Research Coordinator II - Medicine Clinical Trials Office
Posted 1 day ago
Job Viewed
Job Description
Under minimal supervision, coordinates the clinical assessments of the study subjects; analyzes and assists in interpreting moderately complex clinical research data. Prepares grant applications and documents and assists in protocol submissions (for e.g., Institutional Review Board, Grants and Contracts Office).
A Clinical Research Coordinator (CRC) II position is currently available within the Medicine Clinical Trials Office. Duties will include activities such as data collection and management of patient clinical information, timely collection of protocol related samples including shipment to outside entities as required, obtain informed consent, collect, maintain and organize study information, and assist with other day-to-day operations as required. Under minimal supervision, the Clinical Research Coordinator II will manage a workload that includes studies of increased complexity.
**Qualifications**
+ Bachelors degree in sciences or related field.
+ 2 years of clinical research
**Responsibilities**
**Coordinates activities of ongoing clinical trials:**
- Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, administering lifestyle questionnaires.
- Obtain informed consent under supervision of the study investigator(s)
- Educate potential participants regarding study requirements.
- Screen patients for eligibility though through medical record review
- Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
- Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
- Act as liaison between investigator(s) and study sponsor.
- Coordinate activities pertinent to the safeguarding of patients' rights in research.
**Manage study data of ongoing clinical trials under supervision of the Principle Investigator(s):**
- Ensure accurate and complete compilation of subject data through chart reviews.
- Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
- Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
- Maintain source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for recruiting research participants and retaining participants in long-term clinical trials.
- Assist with analyzing data as needed.
**Ensure proper compliance with institutional and regulatory requirements:**
- Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations
- Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
- Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
- Regularly inspect study document to ensure ongoing regulatory compliance. The coordinator will also comply with necessary regulatory responsibilities.
**Performs other job related duties as required, which may include but not limited to:**
- Participate in Investigators' Meeting and assist with coordinating Study Initiation Visits.
- Attend divisional/departmental/institutional educational and training seminars.
- Facilitate sponsor monitoring visits.
- Educate new staff regarding overview of clinical research, office policy and procedures, data submission, workflows and specimen handling.
- Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings.
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $ - $ Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Clinical Research Coordinator I - Medicine Clinical Trials Office
Posted 3 days ago
Job Viewed
Job Description
The Clinical Research Coordinator assists in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information. Assists in preparing grant applications and documents (for e.g., Institutional Review Board, Grants and Contracts Office).
**Qualifications**
+ Bachelors or Masters degree in Science or closely related field.
+ 1-2 years of research experience
**Responsibilities**
+ Collects and records study data. Inputs all information into database.
+ Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
+ Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
+ Assists in preparing grant applications, IRB/GCO for submission and filings.
+ Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.
+ Secures, delivers and ships clinical specimens as required by the protocol.
+ Prepares for monitoring visits.
+ Performs other related duties.
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $58661 - $73530 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Clinical Research Nurse - Academic Office Of Clinical Trials
Posted 8 days ago
Job Viewed
Job Description
At Houston Methodist, the Clinical Research Nurse (CRN) position is licensed clinician who is responsible for, with minimal supervision, supporting, facilitating and coordinating the daily clinical trial activities and plays a critical role in the conduct of the study. This position functions at the Competent level according to the Benner's model of clinical practice. The CRN provides direct patient care effectively and efficiently to research patients under the supervision of the Clinical Trials Manager and Principal Investigator. This position implements clinical research patient care via the research protocol. The CRN position works with the Performance Improvement department, sponsor, and institution to support and provide guidance on the administration of the GCP compliance, financial and other related aspects of the research study. This position serves as a liaison between physicians, patients, staff and sponsors. The CRN position delivers exceptional patient care and adheres to standards and guidelines established by regulatory agencies and Houston Methodist to ensure optimal patient safety and customer service.
**PEOPLE ESSENTIAL FUNCTIONS**
+ Uses therapeutic communication, which includes active listening and teaching, to provide research interventions care to clinical research patients and coordinates with interprofessional team as written in the research protocol. Contributes to teamwork by consistently responding positively to requests for assistance.
+ Provides patient education regarding disease process and involves patient and family in decision-making processes. Consistently evaluates the patient's comprehension and adapts teaching methods accordingly. Advocates on patient/family's behalf to identify and resolve clinical and ethical concerns, utilizing appropriate resources.
+ Facilitates onboarding and orientation process for new staff in conjunction with Clinical Trials Manager. Precepts new clinical research staff in clinical setting. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.
**SERVICE ESSENTIAL FUNCTIONS**
+ Demonstrates ability to manage multiple projects at different stages of the clinical research process (Phase 1-Phase 4).
+ Coordinates pre-site and site initiation visits; trains hospital and clinic nurses/physicians on scientific aspects and protocol requirements of research studies. Attends off-site investigator meetings.
+ Provides comprehensive nursing assessments to develop, coordinate, implement and evaluate activities associated with all phases of clinical research projects. Monitors safety of all research subjects and reports adverse events.
+ Helps drive improvement of department score for patient satisfaction, through peer-to-peer accountability to service standards.
**QUALITY/SAFETY ESSENTIAL FUNCTIONS**
+ Follows the clinical research protocol and nursing process and modifies care based on continuous evaluation of the research patient's condition. Performs nursing functions independently and in collaboration with Principal Investigator as approved by Hospital administration for the conduct of clinical research.
+ Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification as well as perform study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.
+ Collaborates and prepares with Principal Investigator, Institutional Review Board (IRB) and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate and required by the research protocol. Follows International Council for Harmonisation/Good Clinical Practice guidelines.
**FINANCE ESSENTIAL FUNCTIONS**
+ Assisting financial analyst in development of calendar and Medicare Cost Analysis. standard of care procedures vs. research and approving study calendars for Clinical Trials Management System.
+ Identifies, recruits, and consents clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies, as necessary.
+ Enters study related data into Clinical Trials Management System (CTMS) in accordance with Houston Methodist Research Institute policy.
**GROWTH/INNOVATION ESSENTIAL FUNCTIONS**
+ Identifies and presents areas for innovation, efficiency and improvement in patient care operations using evidence-based practice literature. Offers innovative solutions through evidence-based practice/performance improvement projects and activities.
+ Maintains accountability for ongoing professional growth and development. Participates in unit activities. Completes and updates the individual development plan (IDP) on an on-going basis.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
**EDUCATION**
+ Bachelor's degree in Nursing or higher from an accredited school of nursing
**WORK EXPERIENCE**
+ One year acute care or clinical research experience
**LICENSES AND CERTIFICATIONS - REQUIRED**
+ RN - Registered Nurse - Texas State Licensure -- Compact Licensure - Must obtain permanent Texas license within 60 days (if establishing Texas residency) **AND**
+ BLS - Basic Life Support or Instructor (AHA)
**KNOWLEDGE, SKILLS, AND ABILITIES**
+ Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
+ Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
+ Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
+ Demonstrates clinical problem solving and critical thinking using an analytical approach
+ Adapts to multiple ongoing priorities with minimal supervision including, organizing work flow and actively participating in problem-solving
+ Exhibits strong interpersonal and team player skills with all levels of the healthcare team and assures delivery of excellent customer service to all patients, visitors, physicians and co-workers
+ Possesses basic computer knowledge; operates multiple computer systems to include, Hospital Information Systems and Office software to maintain patient and exam documents
**SUPPLEMENTAL REQUIREMENTS**
**WORK ATTIRE**
+ Uniform Yes
+ Scrubs Yes
+ Business professional No
+ Other (department approved) No
**ON-CALL***
_*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below._
+ On Call* No
**TRAVEL***
_**Travel specifications may vary by department**_
+ May require travel within the Houston Metropolitan area No
+ May require travel outside Houston Metropolitan area No
**Company Profile:**
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.
Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.
Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.
Houston Methodist is an Equal Opportunity Employer.
Be The First To Know
About the latest Clinical data managers Jobs in United States !
Oncology Clinical Trials Research RN
Posted 4 days ago
Job Viewed
Job Description
- Evening, night, and weekend shift differential
- Overtime
- On-call pay
At UW Health in northern Illinois, you will have :
• Competitive pay and comprehensive benefits package including: PTO, Medical, Dental, Vision, retirement, short and long-term disability, paternity leave, adoption assistance, tuition assistance
• Annual wellness reimbursement
• Opportunity for on-site day care through UW Health Kids
• Tuition reimbursement for career advancement--ask about our fully funded programs!
• Abundant career growth opportunities to nurture professional development
• Strong shared governance structure
• Commitment to employee voice
Work Schedule: 100% FTE, Day Shift Role. Monday - Friday with work hours between 0700 - 1800; no weekends or holidays. You will work at the Carbone Cancer Center in Rockford.
Qualifications
- Bachelor's Degree in Nursing. Preferred
Work Experience
- 2 years of clinical experience in Oncology services. Preferred
Licenses & Certifications
- Current RN licensure from the State of Illinois. Required
Our Commitment to Social Impact and Belonging
UW Health is committed to fostering a workplace that creates belonging for everyone and is an Equal Employment Opportunity (EEO) employer. Our respect for people shines through patient care interactions and our daily work practices as we work to embrace the knowledge, unique perspectives and qualities each employee and faculty member brings to work each day. It is the policy of UW Health to provide equal opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Job Description
UW Northern Illinois benefits
Clinical Research Assistant II Regulatory - Medicine Clinical Trials Office
Posted 3 days ago
Job Viewed
Job Description
The Regulatory Assistant II plays a vital role in supporting clinical research compliance by managing and maintaining electronic regulatory binders. This position ensures that all regulatory documentation is accurate, current, and audit-ready, while collaborating closely with regulatory affairs teams to uphold institutional and federal standards.
Maintaining regulatory compliance in clinical trials is essential for safeguarding patient safety, upholding ethical standards, ensuring data integrity, and facilitating the development and approval of new medical treatments and technologies. This position offers an opportunity to play a critical role in ensuring regulatory compliance and document management within a dynamic and fast-paced environment. The successful candidate will have the chance to work closely with regulatory affairs professionals and gain valuable experience in the pharmaceutical or healthcare
**Qualifications**
+ Associates Degree in related field or HS Diploma with equivalent related experience
+ Bachelor's degree preferred
+ 1 year of research experience; preferably in a multi-site trial setting
+ Creative problem solving skills; ability to navigate through ambiguous situations
+ Strong organizational, communication and interpersonal skills
+ Ability to manage competing priorities and deadlines in a fast paced environment
+ Proficiency with MS 365 office suite
**Responsibilities**
**Electronic Binder Management:**
+ Assist with all aspects of clinical research regulatory compliance, including document preparation, submission and management for clinical trials.
+ Organize and maintain electronic regulatory binders in accordance with established procedures.
+ Ensure proper version control and document naming conventions are followed.
+ Implement and maintain an efficient filing structure for easy navigation and retrieval of documents.
+ Obtains and maintains required regulatory documentation and study specific regulatory binders for all studies.
**Document Collection and Review** :
+ Collaborate with regulatory affairs team to collect required documents for inclusion in electronic binders.
+ Review documents for completeness, accuracy, and compliance with regulatory standards.
+ Identify and rectify any errors or inconsistencies promptly.
+ Coordinate with stakeholders to address any discrepancies or missing information.
+ Assist team to ensure all site documents, including SOPs and administrative files, are maintained in audit-ready condition.
+ Assist to complete required forms specific to each protocol.
+ Assists with the maintenance of regulatory data in the clinical trial management system (OnCore).
+ Revise submissions in response to identified problems and resolve issues in a timely manner; inform clinical research team on revisions and remedies.
+ Ensure all regulatory documents are readily accessible and organized for inspection purposes.
**Other Responsibilities:**
+ Participate in required teleconferences, on-site meetings as required.
+ Performs all other related duties as assigned.
+ Prepare for study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.
+ Maintain working knowledge of current regulations, regulatory guidance and or local policies.
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $16.5 - $ Hourly. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Project Manager II - Investigator Initiated Clinical Trials/Clinical Research Sponsor Collaboration
Posted 5 days ago
Job Viewed
Job Description
The **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/Clinical Research Sponsor Collaboration (CRSC) within the organization. This role involves coordinating all aspects of trial management, ensuring compliance with regulatory requirements, and facilitating collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work closely with investigators, research teams, regulatory bodies, and institutional leadership to ensure the success of each study in the portfolio.
Project Manager II develops and oversees the operational aspects and scope for employee training. Project Manager II is responsible for developing, implementing, and overseeing comprehensive training programs for new staff within the clinical research teams. This role ensures that new employees are equipped with the knowledge, skills, and resources needed to succeed in their roles while adhering to regulatory requirements and organizational standards. The Training role will collaborate with department leaders, senior staff, and other stakeholders to maintain a consistent and high-quality onboarding experience.
**Qualifications**
+ Bachelors degree or greater preferred, or combination of applicable experience and education; PMP certification preferred
+ 5+ years experience with Masters degree; 7+ years with Bachelors degree, of prior healthcare industry experience required, preferably in the areas of project management, change management, health care delivery re-design or integration, health policy reform.
+ Minimum of 5 years of experience in clinical research, including at least 2 years managing investigator-initiated trials preferred.
+ Proven track record in regulatory compliance, project management, and team leadership.
+ Progressive managerial and clinical job related experience specific to area of responsibility.
+ Experience in managing and financial management.
+ Experience in a supervisory capacity preferred.
+ Strong knowledge of GCP, FDA regulations, and other applicable clinical research guidelines.
+ Exceptional project management skills with the ability to manage multiple priorities and deadlines.
+ Effective written and oral communication skills
+ Effective interpersonal skills; able to establish good working relationships and collaborate with networks of employees of all levels; able to foster cooperation in others; creative problem-solver.
+ Proficiency in financial management, including budgeting and resource allocation.
+ Ability to foster a collaborative, supportive, and high-performance team environment.
+ Hybrid work environment with occasional travel required.
+ Flexible schedule to accommodate project deadlines and stakeholder needs.
**Responsibilities**
**_IICT/CRSC: Primary Duties and Responsibilities 75-80%_**
**Portfolio Oversight and Management**
+ Independently manage project teams and collaborations
+ Manage the lifecycle of trials, including start-up, execution, monitoring, and close-out phases.
+ Develop, implement, and maintain systems to track progress, milestones, and deliverables across the portfolio.
+ Prioritize resources and allocate tasks to ensure timelines and objectives are met.
**Regulatory Compliance and Quality Assurance:**
+ Ensure all trials adhere to Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements (e.g., FDA, IRB, ICH).
+ Oversee the preparation and submission of regulatory documents, including protocols, amendments, and safety reports.
+ Conduct regular quality assurance checks to identify and mitigate risks.
**Financial and Resource Management:**
+ Develop and manage budgets, ensuring cost-effective use of resources.
+ Identify funding opportunities and assist investigators with grant applications and budgeting.
+ Monitor financial performance and reconcile expenses to ensure adherence to budgets
**Communication and Stakeholder Engagement:**
+ Serve as the primary point of contact between investigators, research teams, sponsors, and institutional leadership.
+ Facilitate regular meetings with stakeholders to provide updates on project status, address challenges, and ensure alignment with organizational goals.
+ Promote effective communication and collaboration across all teams.
**Team Leadership and Development:**
+ Supervise and mentor clinical research staff involved, fostering a culture of excellence and accountability.
+ Provide training and development opportunities to enhance team performance and competency.
+ Delegate responsibilities appropriately, encouraging team members to excel in their roles.
+ Resolve conflicts and issues within teams.
**Process Improvement:**
+ Identify opportunities to improve workflows and standard operating procedures (SOPs) related to study management.
+ Develop and implement best practices to enhance efficiency, data quality, and compliance.
+ Monitor industry trends and integrate innovative strategies into the program.
+ Ensure that team meetings have structure and clear purposes and goals; facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team.
**_Staff Training Key Responsibilities 20-25%:_**
**Training Program Development and Implementation:**
+ Design and implement a structured training curriculum tailored to various roles within the clinical research team, including Clinical Research Coordinators (CRCs), nurses, and other support staff.
+ Regularly update training materials to reflect current regulations, organizational policies, and best practices in clinical research.
+ Incorporate input from senior leadership, subject matter experts, and team members into training content.
**New Staff Onboarding:**
+ Conduct onboarding sessions to introduce new staff to clinical research processes, organizational expectations, and compliance standards.
+ Provide hands-on training in key areas such as protocol review, patient interactions, regulatory documentation, and data management.
+ Ensure new staff understand and follow Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines.
**Continuous Education and Competency Development:**
+ Assess the training needs of new staff and create individualized learning plans where needed.
+ Conduct periodic evaluations to measure staff competency and identify areas for improvement.
+ Organize workshops, refresher courses, and other opportunities for ongoing professional development.
**Collaboration and Communication:**
+ Work closely with managers and senior staff to identify training gaps and opportunities for improvement.
+ Serve as a liaison between new hires and leadership, providing feedback and addressing concerns during the onboarding process.
+ Foster a supportive environment that encourages learning and growth.
**Documentation and Compliance:**
+ Maintain detailed records of training sessions, attendance, and individual progress.
+ Ensure all training activities are documented in compliance with regulatory and organizational requirements.
+ Support audits and inspections by providing training documentation as required.
**Mentorship and Support:**
+ Pair new hires with experienced mentors to enhance their learning experience and foster team integration.
+ Provide guidance and support to ensure a smooth transition into their roles.
+ Address challenges faced by new hires and offer constructive solutions.
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $ - $ Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Explore opportunities for clinical data managers, who are vital in the pharmaceutical and healthcare sectors. These professionals oversee the collection, management, and analysis of clinical trial data, playing a crucial role in drug development and regulatory submissions. Responsibilities include designing data collection protocols, ensuring data integrity, and working with cross-functional teams to meet project timelines. A career as a clinical data manager offers chances for advancement and contribution to medical advancements.