Senior CRA - FSP - Medical Device - US Central/West Coast
RemoteMontana, United States
Job Summary
Conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure data accuracy through SDR, SDV, and CRF reviews. Apply risk-based monitoring approaches using root cause analysis to identify site process failures, escalate deficiencies, and follow issues through to resolution. Monitor investigator sites and initiate clinical trial sites while ensuring compliance with ICH-GCP guidelines, applicable regulations, and SOPs. Provide trial status tracking and progress updates to the Clinical Team Manager, perform QC checks on CTMS reports, and facilitate communication between investigative sites, the client company, and the project team. Respond to company, client, and regulatory requirements for audits and inspections, and maintain 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
- 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
- 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)
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