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Columbus, Ohio, United States
Onsite
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Coordinate and perform daily clinical research activities in accordance with sponsor-initiated clinical trials conducted in the Department of Psychiatry; recruit, interview and enroll patients; obtain informed consent and ensure consent process is administered in compliance to regulatory and sponsor requirements; coordinate scheduling of patient appointments, procedures, & other testing in accordance with study protocol; conduct study visits including measuring vitals and other safety measures, assist with monitoring patients for adverse reactions to study treatment, procedure or medication, assure communication with sponsors, organize monitoring visits, notify research sponsors & applicable regulatory agencies as needed; assist with collecting and entering data in sponsor's databases; support activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assist with coordinating and preparing for internal and external quality assurance reviews;
Essential Duties
80%: Implements, coordinates and performs daily clinical research activities in accordance with active clinical trials protocols; assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols; recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; ensures initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol; coordinates scheduling and follow-through of surgeries, medical procedures, & other diagnostic testing; collects and documents medical histories; prepares and conducts study visits, participates in the collection, processing & evaluation of vital signs and biological samples; coordinates and documents care of patients; assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications; documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in evaluating patients for compliance related to protocol.
10%: Assists with collecting clinical research data; compiles and enters clinical research data into study database.
5%: Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; completes case report forms.
5%: Attends departmental meetings; attends investigator meetings.
MINIMUM REQUIRED QUALIFICATIONS
Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required. 1 year of relevant experience required. 2-4 years of relevant experience preferred.
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
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The university is an equal opportunity employer, including veterans and disability.
