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HJF is seeking a detail-oriented Quality and Regulatory Compliance Specialist to support our program, The Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) located in Bethesda (Rockledge), Maryland. HJF provides scientific, technical and programmatic support services to ACESO.
The Quality and Regulatory Compliance Specialist will keep track of an ongoing clinical trials system validation process and maintain related documentation for compliance with FDA 21 CFR Part 11 regulations and standards. The Specialist will work closely with the system validation vendor during the validation process through completion, at which time the vendor will no longer provide validation services and the Specialist will solely maintain all related documentation for implementation of a QA compliance strategy to ensure FDA 21 CFR Part 11 compliance for the conduct of international FDA-regulated Investigational New Drug (IND) clinical studies. The Specialist will maintain the validation process methodology to implement and document repeatable and sustainable procedures to ensure ongoing compliance with FDA 21 CFR Part 11 regulations and standards. He or she will be responsible for maintaining QA/QC processes within the RedCap data management software as well as processes related to overall system validation.
The Specialist will work closely with the Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) program which focuses on implementing a clinical research response capable of conducting FDA regulated clinical trials of therapeutics or diagnostics during an outbreak event. The position will be based at HJF headquarters in Bethesda, Maryland, with required travel 1-2 times/year to the JMEDICC site in Western Uganda.
This position reports to the ACESO Clinical Research Data Manager.
Required Knowledge, Skills, and Abilities:
Minimum Education/Training Requirements: Bachelor’s Degree in scientific, engineering, clinical or regulatory fields of study and 5+ years of experience OR Master’s Degree and 3+ years of experience in healthcare industry or related government projects with exhibited knowledge/proficiency in industry standards for computer and clinical trials IND study system validation.
Supervisory Responsibilities/Controls: None
Work Environment: Office with 10-15% international travel
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or other status protected by law.