- 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; presents this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Independently works with external study monitors and/or auditors.
- Works 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 in accordance with local and federal guidelines.
- May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
- May supervise Clinical Research Associates on data entry, data query and resolution.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
- BA/BS Degree is required
- Phlebotomy certification (LPT, CPT I or CPT II) within the state of California from an accredited agency is required; ACRP/SoCRA (or equivalent) certification preferred.
- Minimum of two (2) years of directly related experience is required.
- Working Title: Clinical Research Coordinator I/CPT - Smidt Heart Institute - Cheng Lab
- Department: Heart Institute Operations
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic/Research
- Job Specialty: Academic/Research Services
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
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