Experienced Clinical Research Coordinator

353 CHURCH AVE, Chula Vista CA

Description

EXPERIENCED, SPANISH SPEAKING AND FLEXIBLE COORDINATOR NEEDED WITH SKILLS: 1. Provide study coordination for assigned trials as directed by the Clinical Research Manager; including data coordination and quality control of research data. 2. Provide back-up and support for all areas of clinical research. 3. Complete regulatory paperwork for IRB submissions, annual reviews and study close-out. 4. Ensure that all Serious Adverse Events (SAEs) are reported in a timely fashion to IRB and sponsor. 5. Create and update Regulatory Binder for each assigned study. 6. Phlebotomy certified or experienced. 7. Interact/liaise with study sponsors and investigators in role of study representative. 8. Conduct eligibility screening interviews over the phone and/or in person. 9. Schedule study patient appointments and make reminder calls to patients; send reminder letters and emails as appropriate. 10. Conduct study patient visits per protocol, including screening and follow-up visits, data collection and entry, specimen collection, and other study activities. 11. Communicate clinical trial status to management and staff through meetings and tracking system; maintain related records. 12. Create and update paper and electronic study patient records. 13. Participate in other recruitment/retention activities as needed, including calling potential participants and occasional outreach. 14. Attend trainings, staff meetings, and in-services as required. 15. Assist lab personnel with specimen processing and shipping as needed. 16. May be asked to attend Investigator Meetings for new trials as assigned. 17. Perform other duties as assigned. Knowledge, Skills and Abilities: Preparation of all study documentation such as protocols, amendments, case report forms, SAE reports and study reports are an integral part of this job. Required Experience: Prior experience as a Clinical Research Coordinator in Industry Sponsored trials