Senior CRA - FSP - Medical Device - US Central/West Coast
RemoteMontana, United States
Job Summary
Monitor investigator sites using a risk-based approach, applying root cause analysis to identify process failures and drive corrective actions. Ensure data accuracy through SDR, SDV, and CRF reviews while assessing investigational products via physical inventory and records checks. Manage procedures for FSO, FSP, and government sponsors to guarantee protocol compliance, subject well-being, and audit readiness. Track trial status, update study systems, and facilitate communication between sites, the client, and the project team. Respond to regulatory requirements and audits, maintaining administrative tasks such as expense reports and timesheets.
Required Qualifications
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor)
- Valid driver's license where applicable
- Effective clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manages Risk Based Monitoring concepts and processes
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Effective interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
- Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information)
Desired Qualifications
- Frequent travel, generally 60-80% but more for some individuals
- May also include extended overnight stays
- Exposure to biological fluids with potential exposure to infectious organisms
- Personal protective equipment required such as protective eyewear, garments and gloves
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.