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This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Client’s Standard Operating Procedures (SOPs) as appropriate. The Temporary Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection-ready according to Client’s SOPs and applicable regulations.
Responsibilities include, but are not limited to:
Requirements:
Document Specialist - Level 1 (1-2 Years)
Posted: 11/02/2023
2023-11-02
2023-12-05
Employment Type:
Contract
Job Category: Document Management
Job Number: 3697
Job Description
This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Client’s Standard Operating Procedures (SOPs) as appropriate. The Temporary Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection-ready according to Client’s SOPs and applicable regulations.
Responsibilities include, but are not limited to:
- Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
- Review and classify documents collected from internal and external sources
- Create, maintain, review, and archive hardcopy TMF
- Reconcile essential documents in both hard/soft copies to avoid duplication
- Perform QC and maintenance of the TMF/TMF for assigned studies
- Perform data entry and reconciliation in various clinical systems and tracking tools
- Provide direct TMF support to clinical trial activities conducted by the Client
- Follow up on quality findings
Requirements:
- Bachelor's or Associate's degree and 1-2 years of professional clinical trial experience OR a high school diploma and a minimum of 3 years of clinical support experience with essential regulatory documents
- Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
- Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
- Previous experience working independently and efficiently after training/onboarding
- Strong computer skills (MS Office) including exposure to data/document management systems
- Must be able to work quickly, prioritize effectively, and show attention to detail
- Good communication and interpersonal skills
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