Description
Primary responsibilities include but not limited to:- Assists with all operational aspects of new and ongoing clinical research studies; Provides logistical support to study staff
- Collect, review, track and file essential clinical documents from CRO (or sites) and ensure they are accurate, complete and received in a timely fashion
- Initiate and manage Trial Master File and perform audits as needed
- Develop and maintain tracking systems for various clinical documents which may include regulatory documents, clinical payments, monitoring reports, vendor invoices, etc. and provide EDC support
- Communicate with CRO/vendors to ensure projects move forward according to study timelines and budget
- Manage clinical and non-clinical supplies
- Coordinate investigator meetings including preparing meeting materials and travel details
Skills, Experience & Education:
- Bachelors Degree in a scientific discipline preferred
- Minimum 3 years similar experience in the Pharmaceutical or Biotech industry
- Experience managing clinical trial documents required
- Strong knowledge of GCP and ICH guidelines and other regulatory requirements
- Excellent organizational skills and attention to detail
- Strong written and verbal communication skills in English
- Adaptable team player that is able to asses priorities, multi-task, and meet deadlines
- Displays a high degree of professionalism
- Microsoft Office computer skills
- Oncology therapeutic experience highly desirable