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Research Coordinator III
2 months ago
Cedars-Sinai Medical Center is seeking a highly skilled Clinical Research Coordinator III to join our team at the Smidt Heart Institute. As a key member of our research team, you will play a critical role in the coordination and management of clinical trials, ensuring the highest level of quality and compliance with regulatory requirements.
Key Responsibilities- Manage the clinical research portfolio and daily operations of studies for the investigator or disease group.
- Schedule research participants for research visits and procedures.
- Document thoroughly on Case Report Forms (CRFs) the following: changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintain 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.
- Schedule and participate 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.
- Notify direct supervisor about concerns regarding data quality and study conduct.
- Work closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.
- May involve other regulatory duties, budgeting duties, and assisting with research participant billing and reconciliation.
- Maintain research practices using Good Clinical Practice (GCP) guidelines.
- Maintain strict research participant confidentiality according to HIPAA regulations and applicable law.
- Participate in required training and education programs.
- Work with Training and Education Coordinator to ensure all staff is properly trained and certified.
- Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Offer strategies to improve clinical research efficiency.
- Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans.
- Identify new research opportunities and present to investigators.
- Supervise other clinical research staff in day-to-day operations. Provide input in the performance review of the staff.
- Coordinate and lead routine research meetings.
- Work on both industry sponsor-initiated and investigator-initiated clinical trials.
- Provide training to junior-level coordinators.
- Invoice sponsors and pay clinical trial invoices.
- Prepare and manage clinical trial budgets.
- Supervise other research staff.
- High School Diploma/GED, required.
- Bachelor's degree, preferred.
- ACRP/SOCRA (or equivalent) certification, preferred.
- 5 years of clinical research experience, required.
- Able to perform moderate lifting.
- Able to sit, stand, and walk for prolonged periods of time.
- Able to read papers and online documents.
- Able to operate standard office equipment.
- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
