Welcome page Returning Candidate? Log back in! Clinical Research Coordinator Job Locations US-MA-Bedford Job ID 2025-9165 Type Regular Full-Time Shift 1st Category R&D Overview

Job Summary

 

Provides critical support to Medical Affairs, specifically with the Investigator Initiated Studies (IIS) Program, tracking of Non-Disclosure Agreements (NDAs) and granted study agreements, as well as managing the tracking and shipping of medical devices.

Responsibilities

Key Accountabilities

Maintain accurate records of all NDAs and research agreementsMonitor the status of research agreements and ensure timely executionManage the inventory of medical devices used in Investigator Initiated Studies, including coordination of shipments and returns of loaned devices to and from research sitesMaintain approprate records to support successful reporting for loaned / free-of-charge materials; attend audits of compliance records as neeededMay support the clinical affairs team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating proceduresCoordinate and communicate with investigators, and legal and compliance teams to address any issues or delays Work with logistics and supply chain teams to resolve any shipping issuesPerforms other duties and responsibilities as assigned.

Networking/Key relationships

Medical AffairsOperations (Logistics)Legal and ComplianceExternal Stakeholders (Investigators, clinical study participants, etc) Qualifications

Minimum Knowledge & Experience for the position:

High School Diploma or equivalent required3 years of administrative support experience

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

 

Skills & Capabilities:

Strong working knowledge of Microsoft Word, Excel, and PowerPointDemonstrated written and oral communication skills Detail-oriented and highly organizedAbility to work independently Great attention to detail and exceptional organization skills.Respects the need for compliance to applicable regulatory requirements.

Travel requirements:

Up to 5% of time. Periodic travel may be required to other Werfen sites.

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