Clinical Research Coordinator - Psychiatry

The Ohio State University

3d•Onsite

About The Position

Coordinate and perform daily clinical research activities for sponsor-initiated clinical trials in the Department of Psychiatry. The role involves recruiting, interviewing, and enrolling patients; obtaining informed consent in compliance with regulatory and sponsor requirements; scheduling appointments, procedures, and testing according to study protocols; and conducting study visits. The coordinator participates in collecting and evaluating vital signs and biological samples, monitors patients for adverse reactions, documents patient care and unfavorable responses, and communicates with clinical professionals, sponsors, and regulatory agencies as needed. The position also supports study data collection and entry, regulatory compliance, quality assurance reviews, and departmental and investigator meetings.

Requirements

Bachelor’s degree in Biological Sciences, Health Sciences, Social Sciences, or another medical field, or an equivalent combination of education and experience.
At least 1 year of relevant experience.

Nice To Haves

2–4 years of relevant experience.

Responsibilities

Implement, coordinate, and perform daily clinical research activities in accordance with active clinical trial protocols.
Assist in assessing patient records to identify patients eligible for clinical research protocols; recruit, interview, and enroll patients.
Obtain informed consent and ensure the consent process complies with regulatory and sponsor requirements.
Educate patients and families about the purpose, goals, and processes of clinical studies.
Schedule and ensure completion of initial and follow-up appointments, surgeries, medical procedures, and diagnostic testing according to study protocols.
Collect and document medical histories; prepare and conduct study visits; participate in collecting, processing, and evaluating vital signs and biological samples.
Coordinate and document patient care, monitor for adverse reactions, and notify appropriate clinical professionals about patient responses or complications.
Document unfavorable responses and notify research sponsors and applicable regulatory agencies as needed.
Participate in evaluating patient compliance with study protocols.
Collect clinical research data and compile and enter it into study databases; complete case report forms.
Prepare and submit regulatory documents to applicable governing agencies and support compliance with IRB, FDA, federal, state, and sponsor regulations.
Coordinate, plan, organize, and prepare for external quality assurance and control reviews by IRBs, federal agencies, or industry sponsors.
Attend departmental and investigator meetings.