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Clinical Records Associate - II
- Must meet all requirements for Clinical Records Assistant position and have demonstrated proficiency in all relevant areas.
- Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records and bioanalytical documentation.
- Participate in continued security and maintenance of the Trial Master File (TMF) Room and the GLP Archive room.
- Assist in the development and implementation of procedures for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records and bioanalytical documentation.
- Perform an inventory review for incoming CRO clinical study filesReceive, index, and file preclinical study records and bioanalytical documentation.
- Participate in periodic file room utilization reviews.
- File incoming documents and retrieve documentation from the TMF Room and the GLP Archive room upon request.
- Assist in the development of Trial Master File and non clinical Archive Index SOPs.
- Assist with the training of employees on the TMF and non clinical Archive Index SOPs.
- Create and maintain study specific file structures for clinical (TMF), biometrics preclinical and bioanalytical documentation and file documents accordingly.
- Ensure record filing is kept up to date and is performed accurately.
- Ensure appropriate documentation completed to track archival of files.
- Basic bioanalytical report formatting and maintenance in conjunction with Document processing.
- May provide support during regulatory agency and internal GCP and GLP inspections.
- Assist in the development of electronic tracking/ filing systems
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GDH Consulting, Inc. provides equal employment opportunities (EEO) to all employees and
applicants for employment without regard to race, color, religion, sex, national origin,
age, disability, genetic information, veteran’s status or any other category protected by
law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable
state and local laws governing nondiscrimination in employment in every location in which
the company has facilities and/or employees. This policy applies to all terms and conditions
of employment, including recruiting, hiring, placement, promotion, termination, layoff,
recall, transfer, leaves of absence, compensation, benefits and training.