A leading US biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Clinical Research Associate job opportunity at their offices in California, USA. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records.
- Maintain a working knowledge of clinical, biometrics, and preclinical documents.
- Participate in continued security and maintenance of the Trial Master File (TMF) 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.
- Assist in the development of Trial Master File SOPs.
- Assist with the training of the company's and contract employees on the TMF SOPs.
- Participate in the management of vendor relationships including offsite storage.
- Create and maintain study specific file structures for the company's clinical, biometrics, and preclinical documents and file documents accordingly.
- Ensure record filing is kept up to date and is performed accurately.
- Perform an inventory review for incoming CRO clinical study files; receive, index, and file preclinical study records; responsible for offsite archival of documents; participate in periodic file room utilization reviews; file incoming documents and retrieve documentation from the TMFR upon request.
- Ensure appropriate documentation completed to track archival of files.
- May provide support during TMF-related regulatory agency and internal GCP inspections.
- Assist in the development of electronic tracking/ filing systems.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.