As a Clinical Research Coordinator I, you will perform independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. Your day to day responsibilities will include:
- Scheduling of patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, responsible to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Schedules and participates in monitoring and auditing activities.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information, preset this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May involve other regulatory / institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
- BA/BS degree preferred
- ACRP/SoCRA (or equivalent) certification preferred
- Two (2) years of directly related experience
- Working Title: Clinical Research Coordinator I - Department of Surgery
- Department: Home Dept - Gewertz
- Business Entity: Academic / Research
- City: West Hollywood
- Job Category: Compliance/Quality
- Job Specialty: Research Compliance
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day