Clinical research coordinator - clinical trials office
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- 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 with 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 the study protocol
- Assist with monitoring patients for adverse reactions to study treatment, procedure, or medication and notifies appropriate clinical professionals to evaluate patient response, identify the status of complications, & provide the appropriate level of care
- Document unfavorable responses and notify research sponsors & applicable regulatory agencies
- Assist with collecting, extracting, coding, and analyzing 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 contributes to the establishment of study goals to meet protocol requirements
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