Description
Duties:The Clinical Trial Associate will perform the following tasks with minimal or general supervision as needed:
* Liaise with internal and external stakeholders to support successful study start up.
* Collects, reviews, tracks, and files essential documents from clinical sites and ensure documents required for filing are complete and accurate and provided to appropriate functional representatives in a timely manner in the correct format.
* Perform final review, Quality Control, and approval of essential document package prior to drug release.
* Perform Trial Master File and Investigator Site File set up, maintenance or management in accordance with Industry requirements and Regulations throughout the study duration.
* Performs audit(s) of Trial Master Files as needed, or supports audit efforts.
* Provides additional Clinical Study start up support for study teams as needed.
* Prepares, procures, and tracks mailing of documents, supplies, or other study related materials.
* Updates and maintains tracking systems and tools with status of documents, contracts, invoices, etc.
* Perform other duties as necessary as assigned by management.
SKILL REQUIREMENTS:
* Minimum of two (2) years of related experience in a biotechnology/pharmaceutical industry required.
* Experience with Clinical Trial document management required.
* Knowledge of regulatory requirements related to Clinical Trial document start up and retention required.
* Previous contract administration experience preferred.
* Excellent written and oral communication skills.
* Experience using computer applications and systems including contracts management, Purchase
Order/ERP, demonstrated in-depth knowledge of Excel spreadsheets is preferred.
* Demonstrated experience and ability to manage multiple projects/prioritize.
* Working knowledge of GCP and ICH guidelines and other industry regulations.