Clinical Research QA Manager - NIH

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Research Quality Assurance Manager at the National Institutes of Health in Rockville, MD. This position is estimated to support a hybrid work arrangement including remote and on-site work at the NIH in Rockville, MD. This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Vacation leave as well as paid federal holidays and 401K plan.
• Access to NIH’s unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall:

• 1) Provide quality management support for NIAID Division of Microbiology and Infectious Diseases (DMID) clinical research activities.
• 2) Support the development, implementation, maintenance, and oversite of a clinical quality management system at NIAID including document management, issue management, CAPA development, and quality assurance (QA) activities.
• 3) Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.
• 4) Support the development and implementation of the Division’s electronic Quality Management System (eQMS).
• 5) Stay current with changes to current industry standards and applicable regulations for quality in clinical research.
• 6) Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPAs for internal and external audits.
• 7) Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
• 8) Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities, provide assessment of the impact of any deficiencies, and identify ways to standardized processes to improve quality and/or facilitate efficiency
• 9) Review, track and/or trend routine quality data; coordinate the development of QA-related metric reports.
• 10) Report adverse trends to management with proposed remediation plan. REQUIREMENTS. The contractor must have:
• 1) Bachelor’s degree in a related discipline.
• 2) Minimum of five (5) years of experience in clinical research including work at a research site and/or government agency
• 3) Experience establishing and managing quality management systems for clinical research for IND sponsors (e.g., in pharmaceutical companies, biotechnology companies, or government sponsors).
• 4) Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes; knowledge of electronic clinical quality management systems such as Master Control preferred
• 5) Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.
• 6) Experience conducting or overseeing audits and/or regulatory inspections from the US FDA or similar government regulatory authorities preferred.
• 7) Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) to effectively troubleshoot and solve problems

PLEASE APPLY ONLINE

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position. Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong. #government9398958 Rockville, MD, US Scientific Bachelors Degree Full Time, Temporary Experienced (Non-Manager) On-site Government and Public Sector First Shift (Day)