Role overview

Qualifications

Minimum Bachelor's degree in a life science-related field, RN certification, or equivalent
3+ years of experience in a clinical trials research environment with specific in vitro diagnostics study experience
General knowledge of regulatory requirements and GCP; strong communication and organizational skills
Proficiency with clinical trial systems (e.g., Veeva Vault and Medrio) and excellent organizational skills

Responsibilities

Ensure compliance with protocol, regulatory, and ICH GCP obligations in assigned aspects of clinical site monitoring (site initiation, routine monitoring, maintenance of study files, study close-out, and retrieval of study materials)
Conduct on-site and remote monitoring activities per the Clinical Monitoring Plan, including source document verification for accuracy and integrity
Write and submit reports of investigational site findings and update applicable tracking systems; escalate observed deficiencies and issues as appropriate

Key facts

Remote from: Anywhere
Freelance
Expert & Leadership (>10 years)
Research Assistant
English

Hard skills

In Vitro Diagnostics Clinic Management Systems Good Clinical Practices (GCP) Clinical Monitoring MedDRA Data Integrity Regulatory Compliance Veeva Tracking Systems (Geolocation) Clinical Study Design Clinical Monitoring Remote Administration Nurse Registry Risk Management

Other skills

Multitasking
Time Management
Teamwork
Organizational Skills
Verbal Communication Skills
Social Skills
Problem Solving

About the company

Freenome

Biotechnology

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas. We have raised more than $1.1 billion from leading investors like Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.

Company details

Company typeScaleup

IndustryBiotechnology

Company size201 - 500

Links

Website LinkedIn See all jobs

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Job description

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, Dennis McHugh. 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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