2,671 Clinical Data Specialist jobs in the United States

• Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
• Manages a workload of studies commensurate to level of experience
• Answers data clarifications (i.e. data queries) for each study.
• Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
• Develops source data worksheets specific to each assigned study.
• Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
• Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
• Maintains logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs.
• Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
• Assists multidisciplinary team in research activities.
• Maintains study binders and filings according to protocol requirements and department policy.
• Adheres to all UM and department policies and procedures.
• Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
• Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
• Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Title: Clinical Trials Management Associate

Duration: 06 Months

Location: Foster city, CA

CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.

Responsibilities:
Non-Client sponsored studies:

• Serves as the key operational contact with external investigators and internal stakeholders.
• Able to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety elements and implications.
• Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or Client product support are processed in a timely manner and to high quality.
• Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure study remains on track.
• Maintains efficient collaboration with companys Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.
• Supports study drug planning and shipping activities with Materials & Logistics.
• Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
• Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
• Provides monthly study updates to the appropriate internal stakeholders.
• Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
• Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• Supports and implements Clinical Operations Quality Initiatives.
• Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
• Performs administrative duties in a timely manner as assigned.

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland. This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.

Description of Responsibilities:

• Reports directly to the Program Manager.
• Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
• Defines the trial budget and schedule.
• Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
• Oversees the screening and qualification of potential study subjects.
• Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
• Monitors progress of the trial and reports any issues to the trial director or physician.
• Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
• Reviews and updates all Standard Operating Procedures (SOPs) as required.
• Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
• Provides and/or coordinates all contractually required reports.
• May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
• Other duties as assigned by Supervisor.

Required Degree/Education/Certification:

• Registered Nurse with five (5) years of experience in Clinical Research.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Basic Life Support (BLS -CPR/ AED) certification.

Required Skills and Experience:

• Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of applicable highly complex scientific procedures and techniques relating to position.

Desired Skills and Experience:

• Advanced Cardiac Life Support (ACLS) certification encouraged.

Required Citizenship and Clearance:

• Must be a U.S. Citizen
• Must be able to pass a background check for a NACI.

The Alakaina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Description

CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.

Key Responsibilities:

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• May participates in the recruiting and hiring process for CTMs and supports their professional development
• May mentor other junior team members
• Coaches members of a work team and ensures adherence to established guidelines

• BS/BA degree in nursing, science or health related field with at least 5 years of trial management experience - OR -
• MS/MA degree in nursing, science or health related field with at least 3 years of trial management experience

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Familiar with standard medical / scientific terminology.
• Ability to communicate in a clear and concise manner.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed, ability to travel.

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland .

*This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.*

DESCRIPTION OF RESPONSIBILITIES:

• Reports directly to the Program Manager.
• Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
• Defines the trial budget and schedule.
• Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
• Oversees the screening and qualification of potential study subjects.
• Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
• Monitors progress of the trial and reports any issues to the trial director or physician.
• Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
• Reviews and updates all Standard Operating Procedures (SOPs) as required.
• Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
• Provides and/or coordinates all contractually required reports.
• May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
• Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Registered Nurse with five (5) years of experience in Clinical Research.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Basic Life Support (BLS -CPR/ AED) certification.

REQUIRED SKILLS AND EXPERIENCE:

• Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of applicable highly complex scientific procedures and techniques relating to position.

DESIRED SKILLS AND EXPERIENCE:

Advanced Cardiac Life Support (ACLS) certification encouraged.

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must be a U.S. Citizen
• Must be able to pass a background check for a NACI.

The Alaka`na Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees

"EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans"

The Alaka ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

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