As a Clinical Research Coordinator, a team member will be involved in an array of activities as listed below:
Serve as primary contact for research protocols at affiliated hospitals
Direct the conduct of clinical studies to ensure adherence to the research protocol
Conduct screening, recruitment, counseling and follow-up of study subjects
Participate in initiation visits, investigator s meetings, monitoring visits and close-out visits for assigned clinical trials and implement these trials according to a deadline schedule mutually agreed upon by PI and sponsor/CRO
Participate in Informed Consent Process & Documentation
Perform relevant submissions to IRB/IEC
Report SAEs to the sponsor/CRO and the IRB/IEC
Prepare, update & maintain Site File and patient records
Ensure accurate and complete data entry into case report forms or pre-established computer programmed formats ensuring appropriate source documentation
Advise & alert investigators of potential protocol and regulatory violations