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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical studies, including oversight of the Trial Master File, adherence to GCP regulations, and coordination of cross-functional teams. Proficient in study documentation, vendor management, and data review processes.
Highest-signal resume keywords
Clinical Study ManagementGood Clinical Practice (GCP)Trial Master File (TMF)Electronic Systems (CTMS, Veeva Vault)Vendor 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 Study CoordinationStudy Document ManagementData Review and Query ResolutionSite MonitoringStudy Tracking and Maintenance
Soft Skills
Strong Verbal CommunicationStrong Written CommunicationTeam CollaborationIndependent WorkTask Prioritization
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointSmartsheetSharePoint
Industry Keywords
Clinical TrialsStudy PhasesStandard Operating Procedures (SOPs)Risk ManagementQuality Assurance
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Support Phase 1, 2, 3, and 4 clinical studies with guidance
- Support study and site feasibility, start-up, maintenance, and close-out activities
- Manage study and site essential document review, collection, and tracking
- Support preparation and maintenance of study documents and manuals
- Provide oversight of the Trial Master File (TMF)
- Ensure study documents are received, reviewed, and filed in accordance with SOPs, GCP, and applicable regulations
- Organize study-related meetings, prepare agendas, take minutes, and maintain risk, issue, and decision logs
- Lead and present at study-related meetings as required
- Perform applicable site monitoring and co-monitoring visits
- Address internal and site quality assurance findings from audits
- Manage, coordinate, and oversee third-party vendor activities
- Perform study tracking and maintenance, including study status, enrollment, site queries, deviations, and study-level documents and plans
- Participate in clinical trial team meetings and collaborative efforts such as protocol development and CRO selection
- Support study site oversight, including site performance, metrics, and monitoring report review
- Support study data activities, including data review, query creation and resolution, deviation reviews, and safety reviews
- Work cross-functionally and provide oversight of CRO and vendor activities
- Review and verify contracted vendor activities, including vendor invoice review
- Support study reporting and tracking using applicable systems and technology
- Support study leads in cross-functional alignment of study timelines
- Complete required training, timesheets, expense reports, and CV updates
- Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements
Requirements
What you’ll need- A BA or BS degree, a nursing degree, or an equivalent qualification
- At least 3 years of experience in clinical studies as a SCRA or Lead CRA
- Working knowledge of Good Clinical Practice (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and how they apply to clinical development
- Working knowledge of electronic systems, including the Trial Master File and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint)
- Knowledge of the principles and practices of computer applications in database management
- 10% to 20% travel may be required
- Strong verbal and written communication skills
- Ability to work independently and as part of a team
- Advanced knowledge of Microsoft Word, Excel, and PowerPoint
- Ability to prioritize and manage multiple tasks simultaneously
Benefits
Comp & perks- Premium salary
- Attractive benefits
- Medical care plan: Health, Dental & Vision
- Life Assurance
- Excellent work environment
- Culture of teamwork and collaboration
- People who motivate and face challenges together
- Innovative technology
- Excellent training
- Paid time off
- Life insurance
- Health insurance
- Additional benefit offerings in accordance with the terms of applicable plans
- Additional incentives, bonuses, or other compensation programs may be available for eligible roles
