Description
Responsibilities:- Manages Site Essential Documents review during study start-up, maintenance and close-out period
- Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking of essential documents are received and filed in the CTMF, reviews site documents (including site-specific informed consent forms)for accuracy and follows up as needed
- Ensures tracking of patient status throughout the study at investigative sites
- Provides clinical team support with CTMF filing and management
- Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
- Assists in the preparation of, and may present at investigator vendor meetings and workshops
- Actively involved in the performance of study feasibility assessments
- Adheres to study timelines, quality, and budget for assigned studies
Requirement:
- Bachelors' degree or higher
- 2 years industry experience preferred
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Extensive Trial Master File experience
- Basic knowledge of therapeutic area or disease
- Understanding of study phases and general knowledge of how they apply to clinical development
- Advanced knowledge of Word, Excel, and PowerPoint.
- Strong verbal and written communication skills required.
- Able to handle multiple tasks and deadlines.
- Ability to identify issues and take appropriate actions.
- 10-30% travel may be required