Clinical Research Associate, In Vitro Diagnostics

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join Thermo Fisher Scientific as a Clinical Research Associate, In Vitro Diagnostics and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. You'll provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.

REQUIREMENTS:

• A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.

• Working knowledge of Good Clinical Practices is required.

• Certification as a Clinical Research Professional (CCRP) is a plus

• If certification is not in place, class work/ course work in Good Clinical Practices is required.

• Minimum of 2 years working in the In Vitro Diagnostic or Medical Device Industry. In Vitro diagnostic experience is a plus.

• A Minimum of 2 years demonstrated experience managing in house and/or external clinical studies.

• Experience working with multi-functional project teams is required.

• Computer literacy, including spreadsheet, database and word processing applications required.

• Candidate must be an independent professional who proactively communicates frequently and effectively.

• Must be comfortable working on projects where the project and its team members may be located at other sites.

• Should be at ease with direct communication with internal project team members and external CROs and

• Should be organized and able to work to on multiple projects with tight deadlines.

• Willing to travel away from home on an occasional basis.

• High energy level; positive attitude; works well under stress; assertive and effective communicator.

• Hands-on, action-oriented, and able to implement effectively.