Description
We are seeking a highly organized and detail-oriented Clinical Research Administrative Assistant to support our Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams.
The successful candidate will be responsible for:
- Assisting CRAs and 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.
- Preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.
- Participating in periodic review of study files for completeness.
- Assisting CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Coordinating the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Acting 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:
- High School Diploma or equivalent required.
- 3-4 years administrative support experience.
- Minimum one year clinical research experience strongly preferred.
- 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.
- Basic knowledge of applicable clinical research regulatory requirement, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
IQVIA is proud to be an equal opportunity employer and we are committed to creating a diverse and inclusive environment.
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