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2017-07-27 03:48:05
Job Description Summary:
Key Skills:
Clinical Quality Assurance Director Location: Tampa Florida Area
2017-07-27 03:48:05
Job Type:
Job Description Summary:
- The Director, Clinical Quality Assurance is responsible for the development, implementation and maintenance of Good Clinical Practices (GCP) framework, and to assure execution of established requirements through oversight of the Clinical activities for products.
- Aids in formulating, implementing and maintaining cGCP systems governing the clinical study program.
- Audit clinical sites for initial evaluation/qualification for clinical trials, conducting routine audits during the clinical trials
- Review/oversight of SAEs/AEs appropriately and in timely manner to meet GCP/Sponsor/IRB requirements
- Ensure clinical studies are conducted in compliance with all aspects of study protocol Ensure regulatory reporting to IRB within GCP guidelines.
- Conduct internal audits of the Pharmacovigilance program to ensure safety oversight is adequate.
- Create or approve clinical quality SOP’s Ensure compliance to cGCP and other regulatory requirements with regard to the clinical quality program.
- Attend training seminars and industry group functions to ensure cutting edge knowledge of cGCP and current industry trends. All other duties as assigned.
- Bachelor's degree in a related field, 7+ years of experience Previous Clinical Research Associate or experience in a CRO organization preferred Experience with Quality System
- MasterControl preferred Ability to interpret medical records and clinical source documentation to gauge adherence to clinical protocols and cGCP.
- ASQ Certified Quality Auditor preferred.
- Willing to travel as required. We are proud to be an Equal Employment Opportunity/AA Employer.
- Minorities/Women/Disabled/Veterans are encouraged to apply.
- We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Key Skills:
