Administrative - Clinical Research Coordinator

Job Title: Administrative - Clinical Research Coordinator

Location (On-site, Remote, or Hybrid?): Orange, CA (hybrid)

Contract Duration: 13 weeks

Working hours: Day 4x7.5-Hour (08:30 - 16:00)

Total hours: 40

Floating Clinical Research Coordinator

Certs: CCRC (ACRP) preferred

Schedule: 30 hours per week guaranteed, possible Hybrid schedule based on need

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. This position is directly responsible to ensure that all documentation is timely and accurate and works closely with the PI to ensure strict compliance to study protocols (GCP/ICH).

Duties:

• Reads and understands all correspondence relating to each study assigned. Responsible for all written and verbal communication and the documentation thereof. This will include but not be limited to 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. Role includes proper documentation of IP assignment, temperature and expiration date monitoring, return of used IP, and destruction or return to sponsor.
• Works with subjects/patients to ensure study compliance and understanding of participation requirements (i.e., timeliness of visits, return of study-related materials and at-home documentation.
• Complete, accurate and timely entry (within 7 days of visit) of visit data into study electronic data capture sites when applicable.
• Recruits and retains study Participants.
• Processes, packages, and ships biological samples as required by study or centralized laboratories.
• Organizes and maintains study binders for each participant in a study. Ensures that filing is complete, accurate and consistent among study participants.
• Attends investigators' meetings as required.
• Works with patients to ensure that study requirements are met including appointments, labs, etc.
• Networks and researches potential new studies.
• Performs regulatory functions for existing studies.
• Maintains control over study medications/supplies.

Experience Required:

• Prefer to have a minimum of two years of experience in a Clinical Research setting where 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 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.