Clinical Research Coordinator

Clinical Research Coordinator - 9201037357618_1 Malvern, PA 1 DAYS AGO 22622820 Summary Malvern, PA In-Person Competitive Salary 1 Years Experience Master's degree No Commission 40.00 hours per week / Day Shift / Full-Time Description

Position Title :

Clinical Research Coordinator Position Overview The Clinical Research Coordinator is responsible for overseeing the administrative responsibilities and project management of TELA Bio's clinical operations activities including supporting the execution of company sponsored studies, investigator-initiated activities, and day-to day clinical operation tasks.

Essential Duties and Responsibilities Clinical Trial Support:

Support the set-up and have operational responsibility for the maintenance of the local electronic Trial Master File (eTMF) including document tracking in accordance with ICH-GCP and local requirements. Collaborate with Clinical Project Managers (CPM) or designees during the document collection process to support effective delivery of a study and its documents. Builds and/or imports clinical-regulatory documents into the eTMF ensuring compliance with local and international regulations and guidance. Maintains study documents, ensuring template and version compliance. Ensures important documents under their responsibility are of quality and uploaded in a timely manner to maintain eTMF Inspection Readiness. Assists with the management and/or distribution of study team internal and external communications. Sets-up, populates and accurately maintains information in tracking and communication tools and supports others in the usage of these systems. Reviews study documents ensuring accuracy of content. Ensure that all study documents are ready for final archiving and completion of the local part of the eTMF.

Clinical Contracts and Payments:

Oversees the administrative activities of the clinical trial contracting process including study agreements, NDAs, etc. Maintain proactive communication with institutions, CROs, vendors and finance to process invoices, make payments, and track receipts. Liaison/collaborate with Clinical Project Manager, Investigational Sites, Legal and Compliance to expedite and finalize contracts and amendments.

General:

Create, prepare, and deliver reports to various departments. Receive and forward communications to different staff and departments. Organize meetings and meeting schedules. Perform clerical duties, such as filing, faxing, answering phone calls, and responding to emails. Other duties as assigned include organizing and managing document control and general invoice tracking. Collaborate cross-functionally with regulatory, legal, View the full job description https://www.click2apply.net/NnE2DRc7B78rLuA1ah87r8. Equal employment opportunity, including veterans and individuals with disabilities.

PI285013674 11-9121.01

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