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23 days old

Clinical Research Quality Assurance Specialist - NIH

Kelly Services
Rockville, MD 20851
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 Specialist at the National Institutes of Health 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 NIHs unparalleled resources and niche scientific initiatives


TASKS/SERVICES. The contractor shall:

(1) Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID.

(2) Facilitate working groups to collaborate and write project-controlled documents as part of the quality management system: SOPs, policies, audit reports, etc.

(3) Support the development and implementation of the Divisions electronic Clinical Quality Management System (MasterControl).

(4) Stay current with changes to current GCP/GCLP regulations, including FDA, EU, and other regulatory bodies and guidance bodies.

(5) Lead internal and external audits of the various quality elements to ensure compliance with GCP/GCLP, industry best practices and guidance.

(6) Participate in oversight and management of Investigator Site Audits, Internal Audits, and Clinical Vendors/CROs Quality Programs with guidance from management.

(7) Support the development and/or review of GCP/GCLP audit agendas, audit plans, audit reports, and CAPAs for internal & external audits.

(8) Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.

(9) Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; provide assessment of the impact of any deficiencies.

(10) Review, track, report, and/or observe trends in routine quality data and other QA metrics

(11) Report adverse trends to management with remediation plan.


REQUIREMENTS. The contractor must have:

(1) Bachelors degree in a related discipline.

(2) Minimum of five (5) years of experience in clinical research including quality assurance and quality management

(3) Experience establishing and managing quality management systems for clinical research (e.g. in pharmaceutical companies, biotechnology companies, CRO, or government sponsors).

(4) Working knowledge of the quality management cycle (i.e., Plan-Do-Check-Act (PDCA)) and corrective Action/Prevention Action (CAPA) processes.

(5) Experience with US and international Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) regulations, guidance documents, and industry best practice in all areas of a GxP environment.

(6) Knowledge of electronic clinical quality management systems (such as Veeva, MasterControl, etc.) highly preferred.

(7) Experience building and maintaining relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs), troubleshooting issues, identifying root causes, and systematically resolving problems

(8) Experience with regulatory inspections from the US FDA or similar government regulatory authorities preferred.

(9) Experience conducting or overseeing audits, working at a clinical research site, and/or experience with federal agencies are preferred.


Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.


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 arent 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, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats 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.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-04 Expires: 2022-06-04

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Clinical Research Quality Assurance Specialist - NIH

Kelly Services
Rockville, MD 20851

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