Job Title: 1099 Clinical Research Associate – Endocrinology & Rare Disease Location: San Diego, CA (Remote with Western US Site Travel - local candidates highly preferred) Length : 2+ year study - Approximately 40hrs a week with ramp up in the beginning Job Description: A local biotech company in San Diego is seeking an experienced 1099 Clinical Research Associate (CRA) to support the monitoring of Western US sites for an upcoming Phase III study. This study will involve 50 sites and 100 patients. Key Responsibilities: Conduct site monitoring visits (pre-study, initiation, routine, and close-out) in compliance with GCP, SOPs, and regulatory guidelines. Ensure data integrity, protocol adherence, and patient safety. Serve as the primary point of contact for site staff, addressing issues related to compliance, enrollment, and study procedures. Review site documentation, including regulatory files and source data verification. Collaborate with the sponsor and study team to ensure trial success. Requirements: Therapeutic experience in Endocrinology, Rare Diseases, Pediatrics, and Genetic Disorders required. Previous Phase III trial experience preferred. Strong knowledge of GCP, FDA regulations, and ICH guidelines. Ability to travel as needed to Western US sites. Bachelor's degree in a life science field or equivalent experience. #J-18808-Ljbffr Clinical Research Training Academy
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