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Clinical Trial Assistant
IQVIA. 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 .
Core Competencies
Role fitUse this summary to align your resume positioning with the role.
Demonstrates expertise in clinical documentation management, including Trial Master File (TMF) maintenance and compliance tracking, while effectively communicating and collaborating with clinical teams. Proficient in regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
ATS Keywords
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About the role
Key responsibilities & impact- 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's Degree Required
- 3 years administrative support experience
- Equivalent combination of education, training and experience
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills including good command of English language
- 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
Benefits
Comp & perks- Potential incentive plans, bonuses, and/or other forms of compensation
- Health and welfare benefits
- Other benefits may be offered