Note: The job is a remote job and is open to candidates in USA. Freenome is seeking a Contract Clinical Research Associate to help grow their Clinical Development team. The role involves managing clinical trial monitoring and site management, ensuring compliance with protocols and regulatory obligations, and contributing to the organization's mission of transforming cancer detection.
Responsibilities
- Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials
- Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required
- Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate
Skills
- Minimum Bachelor's degree in a life science-related field, a registered nurse (RN) certification, or equivalent
- 3+ years' experience in a clinical trials research environment required, with specific in vitro diagnostics study experience
- General knowledge of regulatory requirements & GCP
- Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
- High proficiency in Veeva Vault and Medrio
- Strong spoken and written communication skills
- CRA certification by recognized professional organization is a plus, but not mandatory
- Previous experience in the cancer early detection space
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