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Seattle Genetics, Inc.
Clinical Records Specialist
Location: Bothell, Washington
The Clinical Records Specialist is responsible for supporting paper-based and electronic Trial Master File (TMF) activities, including maintaining the Clinical Document Storage Room (CDSR) and contents, and participating in eTMF system processes.
- Maintain the Clinical Document Storage Room and contents, including but not limited to:
- Support controlled access to the CDSR process, including access training and monitoring
- Create and maintain TMF paper file folders per study specific structure
- File Trial Master File paper documents per study specific structure requirements
- Ensure compliance with the TMF document check out/check in process
- Support the record archive and retrieval process
- Support CDSR space management
- Provide user support for the CDSR and TMF
- Order and maintain appropriate CDSR supplies
- Support eTMF activities, including but not limited to:
- Scan paper documents to the eTMF system
- Provide expertise regarding appropriate classification of electronic records
- Provide classification review and approval of electronic records
- Provide user management activities, such as processing user account requests, training, and providing user support
- Adhere to appropriate process documentation, including SOPs, Training Guides and other procedures
- Other tasks as identified by the supervisor
- Experience in clinical trials environment
- Experience managing a TMF
- Strong administrative, organizational, and communication skills
- Good office software skills such as Word and Excel
- Electronic TMF experience preferred
- DIA TMF Reference Model experience preferred
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
To apply for this position, please click on the following link:
Seattle Genetics, Inc.
Reference Job Code: 1701KF-01 #LI-BC1
Seattle Genetics, Inc. is an Equal Opportunity Employer