Sr. Clinical Research Associate (In-house role) - (Berkeley, CA)

Overview This position will assist in the planning and implementation of post-marketing clinical studies including, but not limited to, coordination of medical affairs related study activities to ensure compliance with the protocol, Good Clinical Practice (GCP), government regulations, and overall medical affairs objectives. Responsibilities Daily activities will vary depending on the objectives of each post-marketing or vaccine development study. Manage contract research organization (CRO) personnel, investigators, and study sites to ensure studies are performed in compliance with the protocol, GCPs, government regulations, and overall study objectives. Manage key study parameters including, but not limited to, study start-up activities, supplies preparation, enrollment, data collection, and close-out. Ensure compliance with the study protocol, GCPs, FDA and ICH guidelines, and Standard Operating Procedures (SOPs).