Clinical Document Specialist (eTMF) - Job ID:6655
Responsibilities of the Clinical Document Specialist (eTMF):
- Assist in the development of clinical trial documents including protocols, manuals, SOPs, trackers, policies.
- Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes.
- Assist in updates for all clinical trials tracking tools for Trial Master File (TMF), monitoring visits, enrollment, laboratory samples and clinical trial agents (drugs/biologics), data cleaning, other vendor tracking and training.
- Develop eTMF knowledge with progression toward subject matter expert for eTMF systems.
- Primary contact for internal and external teams regarding eTMF related processes/activities.
Requirements of the Clinical Document Specialist (eTMF):
- BS degree in science or related area.
- Must have 2+ years clinical research experience in industry or Contract Research Organization (CRO).
- Must have experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF.
- Knowledge and training on Good Clinical Practice (GCP) for clinical research studies.
Benefits of the Clinical Document Specialist (eTMF):
- Paid time off
- Medical and dental insurance
- 401K Match
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
Commonwealth Sciences, Inc.