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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in coordinating clinical studies, managing clinical trial management systems, and ensuring compliance with regulatory standards. Proficient in document management, including collection, tracking, and archiving of clinical-regulatory documents.
Highest-signal resume keywords
Clinical Trial Management Systems (CTMS)ICH-GCP KnowledgeDocument Collection and TrackingRegulatory Submissions SupportSite-Level Contracts Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical-Regulatory Document HandlingVersion ControlDocument ArchivingSubmission Ready Standards (SRS)Electronic Trial Master File (eTMF) Management
Soft Skills
CommunicationCoordinationLiaison Skills
Tools & Technologies
SharePointVCVANGEL
Industry Keywords
Regulatory Authority SubmissionsHCO/HCP PaymentsLocal RegulationsEC/IRB SubmissionsClinical Study Coordination
About the role
Key responsibilities & impact- Assist in coordination and administration of clinical studies from start-up through execution and closeout
- Serve as the local administrative main contact and work with CRAs and/or the Local Study Associate Director
- Set up, populate, and maintain client tracking and communication systems such as CTMS, VCV, and SharePoint
- Coordinate and track study materials and equipment
- Coordinate administrative tasks during studies, audits, and regulatory inspections
- Lead practical arrangements and support preparation of internal and external meetings
- Liaise with internal and external participants and vendors
- Prepare, contribute to, and distribute presentation materials for meetings, newsletters, and websites
- Interface with investigators, external service providers, CRAs, data management, and global clinical solutions representatives
- Maintain the local electronic Trial Master File and Investigator Site File, including document tracking
- Upload essential documents promptly to maintain eTMF inspection readiness
- Prepare study documents for final archiving and support CRA closeout activities
- Produce and maintain study documents with template and version compliance
- Manage document layout, language control, copying, printing, distribution, and email archiving
- Collect, prepare, review, and track documents for regulatory applications
- Assist with submissions to EC/IRB and Regulatory Authorities
- Create or import clinical-regulatory documents into global electronic management systems
- Support electronic applications and submissions according to Submission Ready Standards
- Prepare or support site-level contracts
- Prepare, support, or perform HCO/HCP payments in accordance with local regulations
Requirements
What you’ll need- Knowledge of ICH-GCP and local requirements
- Ability to work with clinical trial management systems and electronic management systems, including CTMS, SharePoint, VCV, and ANGEL
- Ability to handle clinical-regulatory documents according to technical standards, including Submission Ready Standards (SRS)
- Ability to support EC/IRB and Regulatory Authority submissions
- Ability to perform document collection, tracking, maintenance, archiving, and version control
- Ability to support site-level contracts and HCO/HCP payments in accordance with local regulations
- English and local-language translation and spell-checking capability, as required