Freenome is seeking a Clinical Research Associate to manage and monitor clinical trials, ensuring compliance and data integrity to support the development of cancer diagnostics.
Requirements
- 3+ years’ experience in a clinical trials research environment required, with specific in vitro diagnostics study experience
- General knowledge of regulatory requirements & GCP
- High proficiency in Veeva Vault and Medrio
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
Other
- Minimum Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent
- 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
- Strong spoken and written communication skills
