Coordinates technical and administrative details involved in a clinical research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

Responsibilities:

1. Conduct patient evaluations and provide study-related treatment interventions in accordance with approved study protocols, ensuring consistency, participant safety, and protocol adherence. Document all assessments, treatments, and participant responses accurately, and communicate relevant findings to the research team to support study implementation and data integrity.
2. Perform medical record reviews to determine potential participant eligibility for research studies and carry out recruitment activities, including participant outreach, prescreening, and enrollment, in compliance with study protocols and regulatory requirements. Ensure accurate documentation, maintain confidentiality of protected health information, and collaborate with investigators and study staff to facilitate efficient participant recruitment. Mileage will be reimbursed for work-related travel (e.g., participant recruitment and outreach activities).
3. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
4. 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.
5. Determines length of visits and coordinates participant schedules with the study team.
6. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
7. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
8. Completes, audits, corrects Case Report Forms (CRF), relays CRFs to sponsor.
9. Assists with negotiating contract budget and payment terms.
10. Maintains regulatory documents.
11. Maintain contact with IRB and prepare and submit/update IRB documents.
12. May perform functions required of the Clinical Research Assistant as necessary.

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.

Minimum Qualifications: EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).

Department may hire employee at one of the following job levels: Research Coordinator (Non-R.N.), III: Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience. Research Coordinator (Non-R.N.), IV: Requires a bachelor's (or equivalency) + 8 years or a master's (or equivalency) + 6 years of directly related work experience. Research Coordinator (Non-R.N.), V: Requires a bachelor's (or equivalency) + 10 years or a master's (or equivalency) + 8 years of directly related work experience.

Preferences: Entry-level Masters or Doctorate in Occupational Therapy or Physical Therapy.