Research Coordinator (Non-R.N.)

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

• 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.
• 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).
• Attend and participate in Investigator and staff meetings. Advise team regarding specific study assignments and timelines.
• Explain and obtain informed consent, medical history and demographics; document in source file and maintain with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Determine length of visits and coordinate participant schedules with the study team.
• Report and track adverse events (AE). Report serious AEs to IRB and sponsor.
• Document all protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor.
• Complete, audit, correct Case Report Forms (CRF), relay CRFs to sponsor.
• Assist with negotiating contract budget and payment terms.
• Maintain regulatory documents.
• Maintain contact with IRB and prepare and submit/update IRB documents.
• May perform functions required of the Clinical Research Assistant as necessary.

Requirements

• IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire.
• Demonstrated human relations and effective communication skills.

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).

• Research Coordinator (Non-R.N.), I: Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree.
• Research Coordinator (Non-R.N.), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
• 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.

Preferences

• Entry-level Masters or Doctorate in Occupational Therapy or Physical Therapy.

Pay

$33,000 - $36,000 annually or hourly, depending on the FTE.

Schedule

Part Time