Clinical Study Coordinator

Clinical Study Coordinator

Requirements

• 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.

Responsibilities

• Coordinate and perform daily clinical research activities in accordance with approved protocols administered by the department of psychiatry.
• Assist with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols.
• Recruit, interview and enroll patients.
• Obtain informed consent and ensure consent process is administered in compliance to regulatory and sponsor requirements.
• Educate patients and families of purpose, goals, and processes of clinical study.
• Coordinate scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol.
• Participate in the collection and processing of biological samples.
• Assist with monitoring patients for adverse reactions to study treatment, procedure or medication and notify appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care.
• Document unfavorable responses and notify research sponsors & applicable regulatory agencies.
• Participate in evaluating patients for compliance related to protocol.
• Assist with collecting clinical research data.
• 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 external quality assurance and control reviews by IRB, federal or industry sponsors.
• Participate in activities to develop new research protocols and contribute to establishment of study goals to meet protocol requirements.

Preferred Qualifications

• 2-4 years of relevant experience preferred.