Senior Clinical Research Associate - FSP - Medical Device
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Thermo Fisher ScientificMedical Devices
United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Comparable to 2+ years as a clinical research monitor
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
- 2+ years of experience as a clinical research monitor.
- Excellent understanding and application of ICH-GCP guidelines and applicable regulations.
- Demonstrated medical/therapeutic area knowledge and medical terminology.
- Proficiency in Risk-Based Monitoring (RBM) concepts and processes.
- Strong critical thinking, root cause analysis, and problem-solving skills.
- Effective oral and written communication skills with medical personnel.
- Good computer skills, specifically Microsoft Office, with the ability to learn new software.
- Valid driver's license.
- Ability to travel frequently, generally 60-80%.
Responsibilities
- Monitor investigator sites using a risk-based approach, applying root cause analysis to ensure compliance.
- Ensure data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring.
- Assess investigational products through physical inventory and records review.
- Document observations, escalate issues to clinical management, and drive resolution.
- Provide trial status tracking and updates to the Clinical Team Manager (CTM) and maintain study systems.
- Identify potential investigators and initiate clinical trial sites per protocol and regulatory obligations.
- Ensure essential documents are complete and maintain audit readiness.
- Facilitate effective communication between investigative sites, clients, and the project team.
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