FSP Principal CTC
Core
Principal Clinical Trial Coordinator providing administrative and technical support to project teams, overseeing study administration, site activation, and process improvement for clinical trials.
Role type
Senior IC clinical trial coordinator (site activation & administration)
Builds
Clinical trial site activation and administrative support for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research
Required skills
Clinical trial coordination, site activation management, regulatory document review, (e)TMF management, feasibility assessment, stakeholder liaison, process improvement, training delivery, data analysis, vendor management, contract negotiation support
Preferred skills
Bachelor's degree, 6+ years of relevant experience, therapeutic area expertise, knowledge of global regulatory guidelines
Technologies
Activate, eTMF, CTMS
Responsibilities
Coordinate and oversee assigned trial activities and site activation critical paths; Perform file reviews and maintain study documentation in (e)TMF; Conduct feasibility visits and develop site lists; Train new staff and provide technical support to project teams; Liaise with local affiliates and investigators to ensure audit readiness and regulatory compliance; Support process improvement initiatives and cross-functional collaboration.
Seniority
Senior, hands-on IC