Description
Responsibilities: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.
* Distributes, collects, and tracks and negotiates study site budgets and site Agreements (CTAs, Amendments, CDAs). Partners with Clinical Teams and R&D Business Operations colleagues to negotiate favorable business terms and budgets with sites and ensures adherence with the overall approved Clinical Trial plan and budgets.
* Provides additional Clinical Study start up support for study teams as needed.
* Reviews, analyzes, and supports negotiation of routine scopes of work, exhibits, budgets, payment schedules to be included as contract attachments for R&D vendor Agreements.
* Coordinates the Contracts Approval Process, including obtaining appropriate approvals and signatures for all R&D Agreements in accordance with corporate policies to ensure compliance and standardization of process.
* Prepares, requests, and tracks Purchase Orders for contracted services across R&D.
* Coordinates receipt, review, tracking and processing of all R&D invoices to ensure timely approval and payment.
* Attends and participates in clinical team and R&D functional meetings as required.
* 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.
Requirements:
* Minimum of two (2) years of related experience in a biotechnology/pharmaceutical industry required; Bachelor's Degree in a scientific field preferred.
* 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.
* Proven ability to build and maintain effective internal and external relationships and successfully interact with various functional areas and levels.
* 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.