Clinical Research Coordinator
Clinical Research Coordinator
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 agreements
- Monitor the status of research agreements and ensure timely execution
- Manage the inventory of medical devices used in Investigator Initiated Studies including coordination of shipments and returns of loaned devices to and from research sites
- Maintain approprate records to support successful reporting for loaned / free-of-charge materials; attend audits of compliance records as neeeded
- May 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 procedures
- Coordinate 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 issues
- Performs other duties and responsibilities as assigned.
Networking/Key relationships
- Medical Affairs
- Operations (Logistics)
- Legal and Compliance
- External Stakeholders (Investigators clinical study participants etc)
Qualifications
Minimum Knowledge & Experience for the position:
- High School Diploma or equivalent required
- 3 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 PowerPoint
- Demonstrated written and oral communication skills
- Detail-oriented and highly organized
- Ability 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.
Required Experience:
IC
Employment Type
Full-Time
