Description
We are seeking a Clinical Research Coordinator to 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.
The successful candidate will 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.
Key responsibilities include:
- Assisting 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.
- Assisting with 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.
- Accompanying CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
The ideal candidate will have:
- A minimum of 1 year of experience in a CTA role.
- Strong communication skills in English (both spoken and written).
- 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.
- 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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.