Trial Delivery Specialist - Clinical Trial Coordinator
Core
Coordinate and facilitate clinical trial activities, serving as a cross-functional liaison and study lead to support project teams and ensure trial execution.
Role type
Clinical Trial Coordinator (Central or Local)
Builds
Clinical trial operations and documentation for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial coordination, regulatory document review, (e)TMF management, study metrics analysis, vendor tracker maintenance, ISF/Pharmacy binder coordination, translation support, MS Office proficiency, clinical database system mastery
Preferred skills
Bachelor's degree, 4+ years of relevant experience, PPD clinical training completion
Technologies
GoBalto, eTMF, clinical trial database systems
Responsibilities
Coordinate assigned trial activities per task matrix; perform department, internal, country, and investigator file reviews; ensure tasks are completed on time and within budget; maintain study documentation and global support systems; support RBM activities; process documents and perform mass mailings; schedule meetings and track minutes; review local regulatory documents; transmit documents to clients and IRB/IEC; analyze and reconcile study metrics; assist with site documentation resolution; maintain vendor trackers; coordinate Investigator Site File and pharmacy materials.
Seniority
Mid-level, hands-on IC