Clinical Research Coord, I

Job Description - Clinical Research Coordinator I (MEM009813) Job Information Title: Clinical Research Coordinator I Location: Fountain Valley/Long Beach Department: Research Administration Status: Full Time Shift: Days Pay Range: $37.27/hr - $54.01/hr Position Summary The Clinical Research Coordinator fulfills the requirements of recruiting, enrolling, and conducting follow‑up of study participants in clinical trials. The Coordinator coordinates trial participation of volunteers with the trial protocol, company SOPs, GCP/ICH guidelines, FDA regulations, and other applicable regulations, working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. After‑hours support and coverage may be needed. Essential Functions and Responsibilities Under direct supervision of the Director of Clinical Operations, Manager of Clinical Operations and principal investigator, the CRC I is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants. Collaborate with the study investigator to determine eligibility of potential participants. Screen potential participants for protocol eligibility, present trial concepts, participate in the informed consent process, and enroll participants. Ensure research quality by complying with SOPs, GCP principles, and applicable federal, state, and local regulations. Coordinate patient care in compliance with protocol requirements, including disbursement of investigational drug and education regarding medication administration; maintain drug accountability when not handled by Research Pharmacy. Review study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug, documenting all findings. Maintain accurate data collection, documentation, entry, and reporting; schedule and participate in monitoring and auditing activities. Maintain current and accurate documentation in regulatory binders as required by regulations and sponsors. Participate in required training and education programs; provide education of other personnel and vendors regarding clinical research. Provide a safe environment for study participants, caregivers, and staff, complying with federal, state, and professional regulatory standards; maintain strict patient confidentiality per HIPAA. Participate in after‑hours support and coverage schedule, if necessary. Qualifications Minimum of two (2) years of clinical research experience required. Knowledge of clinical trial federal, state, and local regulation requirements preferred. Excellent interpersonal and communication skills required. Ability to read and understand clinical trial protocols required. Strong data management skills and attention to detail required. Familiarity with medical terminology/environment required. Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) required. Bachelor’s degree in relevant field preferred. Research certification (ACRP, SoCRA or equivalent) preferred. Current CITI training preferred. Must maintain a valid driver’s license and automobile insurance; travel to physician offices and health system locations required. Primary Location United States-California-Fountain Valley Benefits We offer high‑quality health insurance plan options, including benefits for employees and their dependents, and additional compensation opportunities such as shift differentials and bonuses. #J-18808-Ljbffr MemorialCare Health System