Job Description

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.)

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.

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 isrequired.

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

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

• Minimum of2years working in the In Vitro Diagnostic or Medical Device IndustryIn Vitro diagnostic experience is a plus.

• A Minimum of2yearsdemonstratedexperience managing in house and/or external clinical studies.

• Experience working with multi-functional project teams isrequired

• Computer literacy, includingspreadsheet, database and word processing applicationsrequired

• Candidate must be an independent professional who proactively communicatesfrequentlyand effectively.

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

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

• Should be organized and able towork toon 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.