Clinical Trial Research Coord I- Walnut Creek

Clinical Trial Research Coordinator I – Walnut Creek Job Summary The Clinical Trial Research Coordinator I (CTRC‑I) is a novice level position that, under the clinical direction of the Principal Investigator (PI), provides operational and administrative support for the Kaiser Permanente Northern California (KPNC) PI, the KPNC Clinical Trials Operations Director or designee, and other research staff conducting multiple FDA‑regulated clinical trials. This non‑licensed role works daily under the supervision of an experienced Clinical Trial Nurse, Clinical Trial Research Coordinator, or KFRI‑designated licensed clinical trial research staff member. It supports the protection of the health, safety, and welfare of research participants. Essential Responsibilities Assist with compliance by following the Principles of Responsibility (Kaiser Permanente Code of Conduct), ensuring alignment with KPNC IRB Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies. Help prepare for inspections, audits, and monitoring visits. Maintain the security and confidentiality of participant data (paper or electronic). Schedule participants for study assessments/visits, coordinate required tests, prepare participant packets (instructions, phone numbers, calendars, diaries, etc.). Obtain medical records and test results for all projects/participants; package and ship protocol specimens to sponsor laboratories per IATA/DOT regulations and sponsor guidelines. Coordinate the ongoing informed consent process and document research data promptly; report findings to licensed staff and the PI. Enter study activity onto case report forms (paper or electronic); maintain a database to track enrollment and consents; manage regulatory files and study supplies. Report potential protocol violations or deviations to the PI; support regulatory documentation and sponsor file maintenance. Assist with study closure activities, including collection of close‑out documentation and preparation of files for long‑term storage. Communicate compliance and operational needs with internal and external parties; coordinate IRB communications as required. Participate in training, education, and development activities; attend protocol and sponsor‑initiated meetings; serve on the Clinical Trial Operations Team (CTOT) as requested. Perform quality control activities and support quality improvement initiatives. Maintain confidentiality, privacy, and security of clinical research information; support the efficient use of operational research databases. Education Associate’s degree or higher, or 2 years of work experience in an ambulatory and/or acute health care setting (LVN may be substituted for an Associate’s degree). High School Diploma or General Education Development (GED) required. Additional Requirements Willingness to obtain IATA/DOT certification prior to start date. Current Basic Life Support (BLS) certification required prior to start date. Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program. Proficient in electronic health systems and databases used in a research environment; willing to learn within 3 months of hire. Demonstrate organizational, communication, and interpersonal skills. Demonstrate proficiency in medical terminology and attention to detail. Ability to manage multiple tasks, prioritize effectively, and be flexible and dependable. Ability to work effectively on cross‑functional teams and present a professional manner and appearance. Demonstrate skill in administrative tasks (filing, photocopying, faxing, etc.). Knowledge of GCP, federal, state, and local regulations, including HIPAA and KP policies and procedures. Must be able to work in a Labor Partnership environment. Preferred Qualifications Clinical trials experience preferred. Seniority Level: Entry level Employment Type: Full‑time #J-18808-Ljbffr