Clinical Trial Coordinator II - FSP
By Admin · Clinical Research & Clinical Operations
ROLE OVERVIEW
Supports global clinical trial delivery by coordinating study documentation, site activation, feasibility, regulatory tracking, eTMF/CTMS activities, and project administration. The role contributes to audit readiness, quality delivery, and timely site start-up across assigned clinical trials.
ROLE DEFINITION & RESPONSIBILITIES
- •Coordinate and oversee assigned clinical trial activities according to task matrices
- •Perform department, internal, country, investigator file and eTMF reviews and document findings
- •Support site activation activities, regulatory document tracking, submissions, and critical-path activities
- •Maintain CTMS, eTMF, study trackers, training records, system access information, and trial status data
- •Support feasibility activities including site-list development, site contact, investigator interviews, survey review, and local site tiering
- •Coordinate Investigator Site File and pharmacy binder materials, study supplies, translations, and document transmissions
- •Analyze study metrics and support clarification and resolution of documentation findings
- •Train new personnel, support meetings and minutes, and collaborate with global, local, vendor, client, and internal clinical teams
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree preferred
- At least 2 years of comparable Clinical Trial Coordinator experience
- Hands-on experience with Veeva eTMF and CTMS
- Experience coordinating global clinical trials with local and global team members
- Working knowledge of ICH GCP, applicable regulations, SOPs and clinical trial documentation
- Strong English communication, organization, computer and documentation skills
PREFERRED QUALIFICATIONS
- •Vendor management experience
- •Feasibility and site-start-up experience
- •Experience with regulatory submissions and centralized IRB/IEC processes
- •Experience supporting RBM or systems such as Activate
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global scientific services and technology company. Its PPD clinical research organization supports pharmaceutical and biotechnology companies with clinical development and research services.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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