Clinical Trial Associate
New York City Metro Area, NY US
- Graduate of a secondary education or equivalent education, science degree preferred.
- Minimum of 6 months to 1 year of clinical Trial Associate experience.
- Demonstrate a working knowledge of ICH-GCP and regulatory guidance.
- Solid working knowledge of eTMF platforms.
- Detail oriented, strong interpersonal and organizational skills and ability to multitask.
- Acts as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Ownership of eTMF (electronic Trial Master File) and management of eTMF.
- Sets up, maintains, and reviews regulatory and administrative documents for the eTMF.
- Obtains, reviews, and processes regulatory and administrative documents from investigator sites.
- Tracks site compliance and performance of documentation within project timelines.
- Assists with periodic review of study files including general and investigator site files to ensure all documentation is complete and up-to-date.
*Experienced candidates only please.