Senior Clinical Research Associate (Level I)
On-siteEde, Gelderland, The Netherlands
Job Summary
Conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure audit readiness by applying risk-based monitoring approaches. Monitor investigator sites using root cause analysis to identify process failures, verify data accuracy through SDR, SDV, and CRF reviews, and escalate deficiencies to clinical management for resolution. Manage procedures from various sponsors, initiate site selection, and facilitate communication between investigative sites, the client company, and the project team. Provide trial status tracking, update study systems, and ensure essential documents are complete per ICH-GCP guidelines. This role involves frequent travel (60-80%) with potential for extended overnight stays and exposure to biological fluids. Requires a Bachelor's degree in life sciences or nursing, plus two years of clinical research monitoring experience.
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)
- Frequent travel, generally 60-80% but more for some individuals
- May also include extended overnight stays
- Must be able to lift 50 lbs
Desired Qualifications
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
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