Clinical Research Associate (Contractor)

The role

The Clinical Research Associate is responsible for assigned aspects of clinical trial monitoring and site management. This person will ensure compliance with protocol, regulatory, and ICH GCP obligations.

What you will do

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring
• Perform 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
• Perform source document verification for accuracy and integrity
• Write and submit reports of investigational site findings
• Update applicable tracking systems
• Escalate observed deficiencies and issues as appropriate

Required qualifications

• 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
• 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 have

• CRA certification by recognized professional organization
• Previous experience in the cancer early detection space

Before you apply

• Contractors may be hired through a third-party provider and will be considered contingent workers

About the company

Freenome is an organization dedicated to changing the entire landscape of cancer.