Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines
Job Summary
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Matching Summary
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Skills & Requirements
Must-have
maintain clinical documents and systems
prepare and file clinical documentation
track clinical data flow
manage project communications
Nice-to-have
effective time management
establish working relationships
strong administrative duties experience
Key Requirements
Bachelors Degree in Pharmaceutical or related field
Min. 1 - 3 years of experience in clinical research
Basic knowledge of GCP and ICH guidelines
Computer skills including Microsoft Word, Excel and PowerPoint