This is a temporary to permanent Clinical Research position with the possibility of a hybrid work arrangement if preferred. The position is based in the vibrant city of Orange, CA, known for its charming neighborhoods and proximity to major attractions in Southern California.
The role involves floating between Providence St. Joseph Heritage Medical Group in Orange, CA and the Leonard Cancer Center in Mission Viejo, CA. The candidate should be aware of the permanent hire rate, which is around *** per hour, before accepting the contract.
Certifications and Schedule
- CCRC (ACRP) preferred
- Schedule: 5x8's Days, Hybrid
Additional Details
- Patient Facing Clinical Trials experience required
- Device Management Experience and Bench Trials experience not accepted
- No blood draw in this role
General Summary
Under the supervision of the Medical Office Administrator, the Clinical Research Coordinator oversees the day-to-day functions of multiple clinical research studies. This role is responsible for interfacing with the Principal Investigator, Patient, Sponsor, and the IRB. The position ensures that all documentation is timely and accurate and works closely with the PI to ensure strict compliance with study protocols (GCP/ICH).
Duties
- Read and understand all correspondence relating to each study assigned, including communications with study sponsors, monitors, study subjects/patients, physicians, and laboratories or other study-specified service providers.
- Responsible for all IP accountability specific to each subject and total protocol inventory, including proper documentation of IP assignment, temperature and expiration date monitoring, return of used IP, and destruction or return to sponsor.
- Ensure study compliance and understanding of participation requirements from subjects/patients.
- Complete, accurate, and timely entry (within 7 days of visit) of visit data into study electronic data capture sites when applicable.
- Recruit and retain study participants.
- Process, package, and ship biological samples as required by study or centralized laboratories.
- Organize and maintain study binders for each participant in a study, ensuring complete, accurate, and consistent filing among study participants.
- Attend investigators’ meetings as required.
- Work with patients to ensure that study requirements are met, including appointments, labs, etc.
- Network and research potential new studies.
- Perform regulatory functions for existing studies.
- Maintain control over study medications/supplies.
Experience Required
- Prefer to have a minimum of two years of experience in a Clinical Research setting where the coordinator managed patients. Cardiology/Stroke specialty a plus.
- Device trial experience will not be accepted. Solely data trials experience also not accepted.
- Minimum 2 years experience in a clinical research setting where the candidate managed patients (consent them, perform vitals/EKG, process labs, dispense medication, complete documentation, enter data)
- MUST HAVE EPIC EXPERIENCE Must also have strong computer skills - Outlook, MS Teams, Word, Excel
Additional Information
- Spanish/Korean speaking skills are a plus.
- Candidate commute is preferred to be 30 minutes or less due to traffic in the area.