Administrative - Clinical Research Coordinator

Carenest Health Services•Orange, CA

1d•Hybrid

About The Position

The Clinical Research Coordinator oversees the day-to-day functions of multiple clinical research studies under the supervision of the Medical Office Administrator. The coordinator interfaces with the Principal Investigator, patients, sponsors, and the IRB, and ensures documentation is timely and accurate while working with the PI to maintain strict compliance with study protocols and GCP/ICH requirements. This temporary-to-permanent position floats between Providence St. Joseph Heritage Medical Group Orange in Orange, California, and the Leonard Cancer Center in Mission Viejo, California. The role is patient-facing and may be hybrid if preferred. The schedule is five 8-hour day shifts per week. There is no blood drawing in this role. The rate if hired permanently is around $40 per hour; candidates must be aware of this before accepting the contract.

Requirements

At least two years of experience in a clinical research setting managing patients.
Patient-facing clinical trials experience is required.
Experience managing patients through activities such as obtaining consent, performing vitals and EKGs, processing labs, dispensing medication, completing documentation, and entering data.
EPIC experience is required.
Strong computer skills, including Outlook, MS Teams, Word, and Excel.
Device trial experience is not accepted; device management experience is not accepted.
Solely data-trial experience is not accepted.
Candidates must be aware that the rate if hired permanently is around $40 per hour before accepting the contract.

Nice To Haves

CCRC (ACRP) certification preferred.
Cardiology or stroke specialty experience is a plus.
Spanish or Korean speaking skills are a plus.
A commute of 30 minutes or less is preferred due to traffic in the area.

Responsibilities

Read and understand correspondence relating to assigned studies.
Handle written and verbal study communications and document them, including communications with sponsors, monitors, study participants, physicians, laboratories, and other study-specific service providers.
Manage investigational product accountability for each subject and the overall protocol inventory, including assignment documentation, temperature and expiration-date monitoring, and return or destruction of used product.
Help participants understand study participation requirements and remain compliant, including visit timing, return of study materials, and at-home documentation.
Enter visit data into study electronic data capture sites accurately and within seven days of the visit when applicable.
Recruit and retain study participants.
Process, package, and ship biological samples as required by the study or central laboratories.
Organize and maintain study binders for participants, ensuring filing is complete, accurate, and consistent.
Attend investigators’ meetings as required.
Work with patients to ensure study requirements are met, including appointments and laboratory requirements.
Network and research potential new studies.
Perform regulatory functions for existing studies.
Maintain control of study medications and supplies.