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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong administrative support capabilities in clinical research, with proficiency in managing Trial Master Files and maintaining compliance with regulatory requirements. Effective in communication and collaboration within clinical teams, ensuring accurate documentation and project timelines.
Highest-signal resume keywords
Trial Master File ManagementGood Clinical Practice (GCP)International Conference on Harmonization (ICH)Microsoft Office SuiteClinical Research Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Trial Master File ManagementClinical Document MaintenanceCase Report Form (CRF) TrackingData Flow ManagementRegulatory Compliance Awareness
Soft Skills
Effective Time ManagementOrganizational SkillsWritten CommunicationVerbal CommunicationRelationship Building
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
Clinical ResearchPharmaceuticalAdministrative SupportClinical Trial SuppliesStudy File Review
About the role
Key responsibilities & impact- Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems, including the Trial Master File (TMF), that track site compliance and performance within project timelines.
- Assist the clinical team with preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Requirements
What you’ll need- Bachelor Degree in Life Science or Healthcare.
- 1-2 years administrative support experience or an Intern experience in clinical research or pharma.
- Availability to go to the office: Hybrid position.
- Location: Bogota, Colombia or Mexico City.
- Written and verbal communication skills including good command of English language.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- 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, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.
