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Study Coordinator

Job Summary
Study coordinator for clinical trials of mindfulness-based intervention as a treatment for chronic pain and opioid misuse/opioid use disorder.
    1. Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
    2. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Supervises research assistants as needed.
    3. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
    4. Conducts study recruitment and enrollment.
    5. Coordinates related facility and research equipment.
    6. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
    7. Documents all protocol deviations, and prepares summary report for sponsor.
    8. Completes, audits, corrects CRFs, relays CRFs to sponsor.
    9. Maintains documents as required by FDA guidelines.
    10. May maintain contact with IRB and prepare and submit IRB documents.
    11. May ensure proper collection, processing and shipment (as needed) of specimens.
    12. May perform functions required of the Clinical Research Assistant as necessary.
    13. Other duties as assigned.


Problem Solving:
Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives
Work Environment and Level of Frequency that may be required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
Minimum Qualifications

Bachelor’s degree in a related field, or equivalency required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.

Some departments may require IATA DGR training within six months.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.


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Last Updated: 1/19/23