Qualifications
Key Responsibilities:Ensure compliance with protocols and ICH GCP obligations during site monitoring, including site initiation, routine monitoring, study file maintenance, and close-out procedures. Conduct both on-site and remote monitoring activities as defined in the Clinical Monitoring Plan, verifying source documents for accuracy and integrity. Prepare and submit reports on investigational site findings and maintain tracking systems; escalate any deficiencies or issues as necessary. Essential Qualifications:Bachelor's degree in a life science field, RN certification, or equivalent experience. At least 3 years of experience in a clinical trials research setting, specifically in in vitro diagnostics studies. Strong understanding of regulatory requirements and GCP. Ability to manage multiple tasks, adapt to changing priorities, and proactively address challenges.
About the job
About this Opportunity:
Join Freenome as a Contract Clinical Research Associate and be a vital part of our expanding Clinical Development team. We are looking for a highly organized and effective communicator with extensive experience in managing diagnostics clinical trials. This role involves overseeing clinical trial monitoring and site management, ensuring adherence to Good Clinical Practice (GCP) and regulatory standards. Your passion for clinical research and keen attention to detail will play a crucial role in our mission to revolutionize cancer detection and treatment.
This position reports to Dennis McHugh, the Director of Clinical Operations. While this is a remote position, occasional travel to our headquarters in Brisbane, California, will be required.
