15 Clinical Development Director jobs in Reynoldsburg
Clinical Research Nurse - CCC | Clinical Trials Office
Posted 28 days ago
Job Viewed
Job Description
Clinical Research Nurse to organize and coordinate care of patients on clinical research protocols in Comprehensive Cancer Center to include evaluation of patient eligibility and registration of out/in patients, monitors care and ensures proper follow up.
Responsibilities
Evaluates patient response and complications
Develops and revises patient care orders
Educates and directs protocol compliance with physicians and staff nurses
Assists in developing tools to meet requirements of new protocols
Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials
Collects and enters data for all patients enrolled on protocol
Participates in analyzing research data
Communicates with outside federal or industry sponsors regarding protocol and patient status
Assesses patient reaction to any modifications or treatment that are part of the protocol
Acts as a patient advocate by providing education to and responding to questions from patients about protocols
Works with patients to ensure adherence with the protocol; serves as clinical resource for other CTO disease team members
Job Requirements
Bachelor's degree in nursing, allied medical professions or other health care field or equivalent combination of education and experience required. Current State of Ohio nursing license or other relevant board or interim permit required in appropriate field; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred; considerable experience in a clinical research capacity conducting clinical research trials preferred; considerable experience in providing direct patient care; computer literacy preferred.
The OSUCCC James is the only cancer program in the United States that features a National Cancer Institute (NCI)-designated comprehensive cancer center aligned with a nationally ranked academic medical center and a freestanding cancer hospital on the campus of one of the nations largest public universities.
Clinical Research Coordinator - CCC | Clinical Trials Office
Posted 1 day ago
Job Viewed
Job Description
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact If you have questions while submitting an application, please review these frequently asked questions.
Current Employees and Students:
If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process.
Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:
- Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
- Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Clinical Research Coordinator - CCC | Clinical Trials Office
Department:
CCC | Clinical Trials Office
The Clinical Research Coordinator performs daily clinical research activities in accordance with approved protocols administered by the Clinical Trials Office within the Comprehensive Cancer Center at The Ohio State University Wexner Medical Center.
Responsibilities
- Assist with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols
- Recruit, interview and enroll patients
- Obtain informed consent and ensure consent process is administered in compliance with regulatory and sponsor requirements
- Educate patients and families of purpose, goals, and processes of clinical study
- Coordinate scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with the study protocol
- Assist with monitoring patients for adverse reactions to study treatment, procedure, or medication and notifies appropriate clinical professionals to evaluate patient response, identify the status of complications, & provide the appropriate level of care
- Document unfavorable responses and notify research sponsors & applicable regulatory agencies
- Assist with collecting, extracting, coding, and analyzing clinical research data
- Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations
- Assist with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors
- Participate in activities to develop new research protocols and contributes to the establishment of study goals to meet protocol requirements
Job Requirements
Bachelor's Degree in biological sciences, health sciences, social sciences, or other related field, or an equivalent combination of education and experience required. One year of experience in a clinical research capacity (human subjects) is required; Knowledge of medical terminology desired; Clinical research certification from an accredited certifying agency desired; Computer skills required with experience using Microsoft Office Software applications desired; Must be able to effectively communicate, both face-to-face and in writing, with clinical staff, research participants, and outside collaborators.
Additional Information:
The OSUCCC - James is the only cancer program in the United States that features a National Cancer Institute (NCI)-designated comprehensive cancer center aligned with a nationally ranked academic medical center and a freestanding cancer hospital on the campus of one of the nation's largest public universities.
Location:
James Cancer Hospital (0375)
Position Type:
Regular
Scheduled Hours:
40
Shift:
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
Senior Director, Global Clinical Development CNS
Posted 5 days ago
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Job Description
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
**Key Job Responsibilities**
+ Conceives, implements, and analyzes drug development programs, including:
+ Understanding pharmacology of drugs and unmet medical needs.
+ Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
+ Working with experts and consultants in the field to refine a clinical development strategy.
+ Designing clinical trials for the purpose of meeting specific objectives.
+ Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
+ Implements clinical development programs, including:
+ Co-authoring global clinical development plans with all practical elements.
+ Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
+ Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
+ Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
+ Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
+ Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
+ Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
+ Partners with internal decision makers to evaluate critical decision points.
+ Acts as a signatory for the medical monitoring team.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
+ Participates in NDA development, submission and defense.
+ Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
+ Mentors junior team members.
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in leading a successful regulatory filing.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
**Physical Demands and Work Environment**
Travel (approximately 30 **%** )
See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
**Company benefits** : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
RFP Development Director, Medicaid Clinical Strategies
Posted 5 days ago
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Job Description
How you will make an impact:
+ Strategy Development and Collaboration: Lead the development of innovative physical health clinical strategies and solutions tailored to win high-priority Medicaid procurement opportunities. Partner with physical health clinical teams and SMEs across the organization to formulate robust responses that align with state priorities.
+ Comprehensive Capture Plan Creation: Responsible for developing deep insights-driven functional area market capture plans that illustrate competitive solutions meeting state-specific needs and goals. Utilize strategic intelligence to craft state-of-the-art clinical solutions within proposal responses.
+ Cross-Functional Coordination: Collaborate cross-functionally with growth partners such as health plan leadership, and leaders in various functional areas, including Medicaid operations, quality, claims, payments, data analytics, and clinical SMEs, to execute a cohesive and responsive proposal capture plan.
+ Proposal Development: Work closely with the Business Development Leader and growth partners to build and promote agreement on bid strategy, ensuring compelling and accurate representation of strategic vision in proposal sections. Gather and synthesize clinical use cases and proof points for proposal content, enhancing the persuasiveness of the responses within each RFP.
+ Risk Management and Delivery Facilitation: Monitor, evaluate, and escalate risks and strategy delivery concerns, ensuring robust execution of the capture plan. Provide significant input throughout executive team reviews to shape content, solutions, and messaging that resonate with proposal evaluators.
Requires a BA/BS degree in business, public health, nursing, medicine, health care delivery, or a related field and a minimum of 7 years work related experience in Medicaid business and a minimum of 5 years of experience leading cross functional teams; or any combination of education and experience, which would provide an equivalent background.
Highly preferred skills and experiences:
-Physical health clinical care expertise. Experience creating clinical solutions and clinical strategies, population health and whole health clinical approaches and experiences.
-Medicaid Managed Care business development experience such as proposal strategy, RFP strategy, and/or capture strategy.
-Experience working inside a Medicaid Health Plan, a corporate Medicaid growth team, or a clinical team supporting the growth and business development functions for Medicaid plans.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
Senior Clinical Research Associate - Oncology Trials
Posted 5 days ago
Job Viewed
Job Description
Key Responsibilities:
- Manage a portfolio of clinical trials, ensuring adherence to study protocols, regulatory requirements, and company SOPs.
- Conduct site selection, initiation visits, routine monitoring visits, and close-out visits.
- Verify the accuracy, completeness, and validity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Ensure all regulatory and safety information is maintained and reported in a timely manner.
- Act as the primary point of contact for study sites, investigators, and site staff, providing guidance and support.
- Identify, resolve, and escalate site-level issues promptly to ensure study timelines are met.
- Develop and manage study timelines, budgets, and resource allocation.
- Train and mentor junior CRAs and site personnel on study-specific procedures and GCP.
- Prepare monitoring reports and ensure follow-up actions are completed.
- Collaborate with internal teams, including project management, data management, and medical monitors.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree is a plus.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
- Extensive knowledge of ICH-GCP guidelines and other relevant regulatory requirements (FDA, EMA).
- Proven experience in all phases of clinical trial monitoring and management.
- Strong understanding of clinical trial processes, medical terminology, and data management systems.
- Excellent organizational, time management, and problem-solving skills.
- Outstanding written and verbal communication skills, with the ability to present complex information clearly.
- Proficiency in using clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Ability to travel up to 50% to clinical sites as required.
- Commitment to patient safety and data integrity.
Clinical Research Nurse
Posted today
Job Viewed
Job Description
Job Description
Functions as a Research Nurse to plan, organize and coordinate the care of patients on clinical research protocols in the Department of Obstetrics and Gynecology; evaluates and identifies eligibility of patients for consideration of participation in clinical studies; administers informed consent to study participants; serves as a patient advocate monitoring care and ensuring appropriate and timely follow-up care is scheduled and carried out; collects and processes biological specimens as required by protocol; evaluates patient response and complications; develops and revises patient care orders; educates and directs protocol compliance with physicians and staff nurses; assists in developing tools to meet requirements of new protocols; manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials; serves as clinical resource for other disease team members; collects and enters data for patients enrolled on protocol; participates in analyzing research data; communicates with outside federal or industry sponsors regarding protocol and patient status; assesses patient reaction to any modifications or treatment that are part of the protocol; provides educational and informational materials to study participants and their families about purposes, goals and objectives of study and what to expect as a study patient; responds to questions and concerns from patients about protocols; works with patients to ensure adherence with the protocol; serves as clinical resource for other disease team members.
Minimum Education Required:
Bachelor's Level Degree or equivalent combination of education and experience with a Major in nursing
Required Qualifications
Bachelor's Degree in nursing required or equivalent combination of education and experience; current State of Ohio Nursing license or interim permit required.
Desired Qualifications
Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred; experience in a clinical research capacity conducting clinical research trials preferred; considerable experience in providing direct patient care desired; experience in labor and delivery nursing desired; ability to work flexible hours (evenings) required.
Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.
FUNCTION/SUBFUNCTION: Research and Scholarship/Clinical Research
CAREER BAND: Individual Contributor- Clinical
CAREER LEVEL: C2
Occasional evening hours may be required.
Travel to OSUWMC outpatient sites may be required as needed. The locations include, Outpatient East, New Albany, Dublin, and Upper Arlington.
Clinical Research Senior Coordinator
Posted today
Job Viewed
Job Description
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact If you have questions while submitting an application, please review these frequently asked questions.
Current Employees and Students:
If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process.
Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:
- Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
- Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Job Title:
Clinical Research Senior Coordinator
Department:
Nursing | College Administration
Clinical Research Senior Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the department; oversees, implements and coordinates conduct of daily activities of research studies; leads patient enrollment activities and ensures informed consent authorization is obtained and administered in compliance to regulatory and sponsor requirements; participates in collecting, extracting, coding, and analyzing clinical research data (including neuropsychological tests, EEG); assists with activities to ensure compliance with Institutional Review Boards (IRB) regulations; participates in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participates in internal quality assurance audits; participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists with preparation and submission of publications, research reports, and grant proposals.
This is a grant funded position with an anticipated duration of 3 years; the possibility of extension will be based on funding and budget.
Additional Information:
Minimum Education required, degree level and focus area: Bachelor's degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
Minimum Years of Experience required: 3 years of relevant experience required, 4-6 years of relevant experience preferred.
Desired experience: Health care knowledge or experience preferred. Strong communication skills and work ethic are desired. Ability to work without intense supervision. This position requires reliable transportation to Stephanie Spielman Breast Center for data collection. Some weekend and evening hours required. Experience using the EPIC electronic health record required; knowledge of REDCap strongly preferred.
Function: Research and Scholarship
Subfunction: Clinical Research
Career Band: Individual Contributor - Specialized
Career Level: S3
Salary Range: $58,700 - $77,200
Location:
Newton Hall (0275)
Position Type:
Term (Fixed Term)
Scheduled Hours:
40
Shift:
First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.
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Clinical Research Specialist 2
Posted 1 day ago
Job Viewed
Job Description
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact If you have questions while submitting an application, please review these frequently asked questions.
Current Employees and Students:
If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process.
Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:
- Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
- Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Job Title:
Clinical Research Specialist 2
Department:
Medicine | Clinical Trials Management Office Earnings
Clinical Research Specialist to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Department of Surgery Division of Trauma Critical Care and Burn; assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols; recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care; documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data; generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.
Minimum Education Required
Bachelor's Level Degree or equivalent combination of education and experience with a Major in allied medicine professions or biological sciences
Required Qualifications
One year experience in a clinical research capacity conducting clinical research studies required.
Preferred Qualifications
Experience or knowledge in Neurosurgery preferred; knowledge of medical terminology desired; clinical research certification from an accredited certifying agency desired; computer skills required with experience using Microsoft Software applications desired.
Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.
Function/Subfunction: Research and Scholarship/Clinical Research
Career Band: Individual Contributor- Specialized
Career Level: S2
Additional Information:
This is a patient facing position and the employee is required to be onsite. In addition, evenings, weekends, and on-call hours will be required, including holidays.
Location:
Medical Center Tower (0870)
Position Type:
Regular
Scheduled Hours:
40
Shift:
Varying Shifts
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
Clinical Research Senior Coordinator
Posted 1 day ago
Job Viewed
Job Description
Clinical Research Senior Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the department; oversees, implements and coordinates conduct of daily activities of research studies; leads patient enrollment activities and ensures informed consent authorization is obtained and administered in compliance with regulatory and sponsor requirements; participates in collecting, extracting, coding, and analyzing clinical research data (including neuropsychological tests, EEG); assists with activities to ensure compliance with Institutional Review Boards (IRB) regulations; participates in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participates in internal quality assurance audits; participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists with preparation and submission of publications, research reports, and grant proposals.
This is a grant funded position with an anticipated duration of 3 years; the possibility of extension will be based on funding and budget.
Department:Nursing | College Administration
Location:Newton Hall (0275)
Position Type:Term (Fixed Term)
Scheduled Hours:40
Shift:First Shift
Minimum Education required, degree level and focus area: Bachelor's degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
Minimum Years of Experience required: 3 years of relevant experience required, 4-6 years of relevant experience preferred.
Desired experience: Health care knowledge or experience preferred. Strong communication skills and work ethic are desired. Ability to work without intense supervision. This position requires reliable transportation to Stephanie Spielman Breast Center for data collection. Some weekend and evening hours required. Experience using the EPIC electronic health record required; knowledge of REDCap strongly preferred.
Function: Research and Scholarship
Subfunction: Clinical Research
Career Band: Individual Contributor - Specialized
Career Level: S3
Salary Range: $58,700 - $77,200
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
The university is an equal opportunity employer, including veterans and disability.
Clinical Research Associate II
Posted 5 days ago
Job Viewed