Send this job to a friend
Department: MedStar Community Clinical Research Center
Schedule: Full-time
Shift: Days
Job Details:



    Nature and Scope of Position:        

    Implements and coordinates clinical trials at the MCCRC or MedStar Health affiliates in conjunction with GCP and FDA regulations.  Possesses knowledge in clinical research and organizational skills with the ability to manage multiple responsibilities and activities with close attention to detail. 


    Principal Duties and Responsibilities:

    Coordinates protocol implementation for clinical trials, including but not limited to:

    1.               Administrative

    §    Works with the Principal Investigator and Administrative Director to develop valid business plans for research projects. This includes appropriate use of the research feasibility tool and cost analysis.

    §    Prepares and submits regulatory documents and supporting forms including appropriately modified consent forms to the Office of Research Integrity and Institutional Review Board.

    §    Initiates and maintains required clinical and regulatory files.

    §        Responds in a timely and accurate fashion to directives given by the IRB, ORI, FDA, National Institutes of Health or the sponsor of the research study.

    §         Participates in conferences, departmental meetings, continuing education, investigator  meetings, site initiation, interim monitoring and closeout study visits as assigned.

    §    Prepares and analyzes regular reports of research activity, including monthly billing forms, IRB continuation and closure requests, and patient enrollment logs.

    §    Prepares and submits accurate weekly billing sheets detailing expenses and reimbursements for milestones met as part of the research activity.

    2.                   Clinical

    §  Communicates with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress.

    §  Administers and/or dispenses investigation agents, under the auspices of the principal investigator or responsible clinician, as needed.

    §  Monitors each patient’s study progress to fulfill protocol and sponsor requirements.

    §  Completes required measures and milestone activities appropriate to the clinical course and monitoring of study subjects as required per protocol, including but not limited to: visits, laboratory tests, vital sign measurement, EKGs, health status assessment, adverse event monitoring and reporting, and investigational drug dispensing (if appropriate).

    §  Collaborates with PI and Coordinators to establish recruitment strategies, complying with regulations and guidelines.              


    §  Develops patient screening and recruitment, study enrollment, and participant follow-up tools and plans.

    3.                   Assists MCCRC staff and/or MRI investigators in study related activities, as assigned.

    4.                   Seeks and avails self of opportunities to develop and advance knowledge base in clinical study areas.

    5.       Performs other duties as assigned.

    Minimum Qualifications:


    Education:           Minimum Associate Degree in Nursing with eligibility for RN licensure and certification 


    Experience:        Experience in clinical research and or community outreach programs preferred. Registered Nurse or Licensed Practical Nurse preferred.  High level Medical Assistant will be considered.  

Click Here to Apply Online
Current MedStar Health Research Institute Employees Click Here to Apply Online

back to top