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Clinical Trial Associate- TMF

Job Attributes

Job Id:

18715

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

Not Defined

Business Unit:

Piper Companies

JOB DESCRIPTION

This position will report to Senior Project Management within the Clinical Operations and Project Management department 

The position will provide support for the generation and maintenance of a paper and or electronic Trial Master Files (TMF) with a focus on maintaining Inspection Readiness throughout the lifecycle of a given Clinical Trial. Critical functions include assuring that assigned TMFs are complete, accurate and timely.  Specific duties include the following:

  • Receipt, review, and filing of documents submitted for the TMF
  • Coordination of timely resolution of document issues with the documents Authoritative Sources including Clinical Research Sites, Data Management Centers, Sponsors and other trial collaborators.
  • Generation of Certified Copies when applicable
  • Creation and maintenance of a document inventory
  • Generation of Metrics Reports to assist sponsors with trial oversight and demonstrates quality, completeness of the TMF as well as timely submission of TMF documents.
  • Reviews regulatory documents to ensure completeness in accordance with sponsor requirements, ICH/GCPs, FDA Regulations, EMA, MHRA and other health authority regulations.
  • Must have excellent time management skills and be able to adhere to strict project timelines and expectations.
  • Able to multi-task during the review/processing and preparation of essential regulatory documentation.

Requirements:

Bachelor’s/Master’s Degree from an accredited institution (preferred major/focus\: Health Sciences); Familiarity with CTMF requirements and practices is preferred.  Prior experience with generation and maintenance of Trial Master Files and/or Document Management is a plus.  Experience with Electronic Data Management Systems (EDMS) and performing in the role of Clinical Research/Trial Associate (field or in-house) or Study Coordinator is a plus.  Other requirements include a strong attention to detail, strong Microsoft Office skills, and the ability to adapt to various client requirements.  One to two years applicable work experience is preferred.

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Job Id:

18715

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

Not Defined

Business Unit:

Piper Companies