Job Overview:
We are seeking a highly motivated and detail-oriented Clinical Trial Assistant to join our team. The Clinical Trial Assistant will serve as the unblinded point of contact for logistics vendors and unblinded Clinical Research Associates (CRAs), responsible for managing various aspects of clinical trial logistics and documentation. The successful candidate will have excellent organizational skills, the ability to work independently, and strong emotional intelligence. This role requires proficiency in Microsoft Office applications and at least 1 year of experience managing clinical trials in a pharmaceutical company, Contract Research Organization (CRO), or clinical trial site.
Key Responsibilities:
- Serve as the unblinded point of contact for logistics vendors and unblinded CRAs.
- Generate and review shipment documents, including batch records, Certificate of Conformance (CoRC), temperature logger data, etc.
- Manage investigational product (IP) inventory and ensure proper storage and distribution.
- File unblinded Trial Master File (TMF) documents in accordance with regulatory requirements.
- Review unblinded monitoring reports and address any discrepancies or issues as needed.
Qualifications:
- Good emotional intelligence skills, with the ability to communicate effectively and maintain professionalism in challenging situations.
- Ability to work independently and manage multiple tasks simultaneously, with strong attention to detail.
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
- At least 1 year of experience in relevant experience managing clinical trials in a pharmaceutical company, CRO, or clinical trial site.
- Bachelor's degree in a relevant field (e.g., life sciences, healthcare, etc.) preferred.
