CLINICAL RESEARCH ASSOCIATE (CRA)

SCOPE

Exciting opportunity to join the growing Clinical Operations team in a market-leading company with a robust clinical oncology portfolio. As Clinical Research Associate, you will be responsible for the initiation and documentation of multi-site clinical trials. With a team-oriented culture and a successful pipeline, this company is the place to continue growing in your career.

RESPONSIBILITIES

• Create and maintain documentation and tracking for site initiation activities, site management, monitoring visit findings, subject screening and enrollment
• Conduct and document pre-study, initiation, progress and closeout monitoring visits
• Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines
• Review CRF, Informed Consent Documents and verification of data management queries in to meet clinical study timeline
• Oversee vendors and CROs, including reviewing invoices and expenses

REQUIREMENTS

• Bachelor’s degree in life sciences or health care required
• 2+ years CRA experience in biotechnology, biopharmaceuticals or pharmaceutical company required
• Experience in oncology clinical trials required
• Monitoring experience required
• Strong communication and writing skills
• Strategic thinker with the ability to thrive in a collaborative, fast paced environment
• Travel required (up to 40%)

My team and I are working on a number of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or e.mato@hamlynwilliams.com.