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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 documentation and regulatory compliance, with a strong focus on maintaining the Trial Master File and adhering to GCP and ICH guidelines. Proficient in administrative support, effective communication, and time management within clinical research environments.
Highest-signal resume keywords
Clinical Documentation ManagementRegulatory Compliance (GCP, ICH)Administrative Support ExperienceMicrosoft Office Suite (Word, Excel, PowerPoint)Effective Communication Skills
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 DocumentationTrial Master File ManagementCase Report Form TrackingClinical Data ManagementProtocol Requirements Knowledge
Soft Skills
Time ManagementOrganizational SkillsInterpersonal Skills
Certifications & Qualifications
Bachelor's Degree
Industry Keywords
Clinical ResearchRegulatory RequirementsStandard Operating Procedures
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Assist Clinical Research Associates and Regulatory and Start-Up teams with updating and maintaining clinical documents and systems, including the Trial Master File
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures
- Review study files periodically for completeness
- Assist with preparation, handling, distribution, and tracking of Clinical Trial Supplies
- Track and manage Case Report Forms, queries, and clinical data flow
- Act as a central contact for designated project communications, correspondence, and associated documentation
- May accompany Clinical Research Associates on site visits to assist with clinical monitoring duties after required training
Requirements
What you’ll need- Bachelor's Degree Required
- 3 years administrative support experience
- Equivalent combination of education, training and experience
- Working knowledge of Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills, including good command of English
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Awareness of applicable clinical research regulatory requirements, including GCP and ICH guidelines, as provided in company training
- Knowledge of applicable protocol requirements, as provided in company training
Benefits
Comp & perks- Health and welfare benefits may be offered
- Incentive plans, bonuses, and/or other forms of compensation may be offered
