Job Application for Clinical Research Associate (Contractor) at Freenome

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About this opportunity:

At Freenome, we are seeking a contract Clinical Research Associate to help grow the Freenome Clinical Development team. The ideal candidate is well-organized, an excellent communicator and experienced in diagnostics clinical trial management. This person is responsible for all things related to assigned aspects of clinical trial monitoring and site management. You are passionate about clinical research, attention to detail and Good Clinical Practice, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Director of Clinical Operations. This role will be a remote role with occasional travel, as required, to our Brisbane, California headquarters.

What you’ll do:

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

Must haves:

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

Nice to haves:

CRA certification by recognized professional organization is a plus, but not mandatory
Previous experience in the cancer early detection space

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

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A principal investigator at one of your clinical trial sites for a novel IVD cancer screening test wants to make a change to the study protocol that would alter the sample collection and processing instructions critical to the device's performance claims. Briefly describe the steps you, as the CRA, would take to ensure this change is handled in compliance with ICH GCP and relevant IVD Medical Device Regulations (e.g., FDA 21 CFR Part 812, ISO 20916:2019). What are the key internal and external stakeholders that must be notified, and what document updates are immediately required?

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Clinical Research Associate (Contractor)

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