IQVIA is looking to solve the problem of conducting clinical trial activities in accordance with applicable regulations to support groundbreaking studies and improved patient outcomes.
Requirements
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Clinical Research Coordinator experience within a similar setting
- Clinical skills experience including obtaining vitals, phlebotomy, EKG, etc.
- Knowledge and experience of site operations and the drug development process
- Computer proficiency in use of Microsoft Word, Excel
Responsibilities
- Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved
- Obtains informed consent of research subjects
- Collects patient/research participant history
- Collects and maintains source documentation
- Manages inventory and administers test articles/investigational product to participants
- Performs data entry and query resolution
- Supports the collection and review of required essential study documents and reports
Other
- Ability to coordinate as primary CRC 1-3 studies on average of low to medium complexity, with oversight by a manager or higher-level CRC
- Develops strong working relationships and maintain effective communication with study team members
- Complies with Avacare and Sponsor policies, standard operating procedures (SOPs) and guidelines
- May be asked to perform special project responsibilities and travel to other clinic locations, within the area, when needs arise
- Must be able to work on-site in Versailles, KY
