FSP Sr. CRA I (Alzheimer's experience)- East and SE region
RemoteUnited States
Job Summary
Conduct remote or on-site visits to assess protocol and regulatory compliance, manage site processes, and ensure audit readiness in accordance with ICH-GCP guidelines. Monitor investigator sites using a risk-based approach, apply root cause analysis to identify failures, and escalate deficiencies to clinical management for resolution. Track trial status, update study systems, and facilitate communication between investigative sites, sponsors, and project teams. Initiate clinical trial sites, conduct file reviews, and participate in investigator meetings to ensure site acceptability. Maintain administrative tasks including expense reports and timesheets while managing procedures from various monitoring environments. Requires 1+ year of Alzheimer's therapeutic area experience, 60-80% travel, and a valid driver's license.
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
- A minimum of 1 year of travel monitoring experience in therapeutic area Alzheimer's
- 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)
- Must be able to lift 50 lbs
Desired Qualifications
- Must be available for weekend shifts
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