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Center Administrator, Quality Assurance

Employer
The George Washington University
Location
Washington, DC

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Faculty Jobs
Arts & Humanities
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details

Posting Details

I. DEPARTMENT INFORMATION

Job Description Summary:

The Clinical Research Group is part of the Research Center for Neglected Diseases of Poverty, located at the George Washington University School of Medicine and Health Sciences. This position will support the Clinical Research Group (CRG) within the SMHS Departments of Medicine and Microbiology, Immunology & Tropical Medicine in the implementation and maintenance of the group’s clinical and laboratory quality management systems.

This experienced position performs research of the CRG and also handles many outreach, operational, and administrative functions of the research center, to include data collection, annotation, report generation, and relationship-building. This research position often handles administrative duties operationally, in addition to providing strategic input for the research center. This role performs duties in support of the administration and ongoing support of the CRG, including logistics, documentation oversight, and collaborating on data quality procedures. The position typically collaborates on evaluating research methods, procedures, and techniques based on established objectives. Performs a variety of Quality Assurance activities that ensure compliance with FDA, ICH and GxP guidelines and regulatory requirements. This includes:

- Manages the day-to-day quality operations via oversight of all elements of the CRG’s Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training
- Manages all aspects of group’s training system including maintenance of training records, oversight of training compliance, and periodic auditing of training records.
- Collaborates to identify quality issue root cause and track CAPA investigations; work with clinic and/or lab staff to bring investigations to completion.
- Provide direct operational support for internal/external GxP audits, and support regulatory inspections, as needed.
- Prepare Standard Operating Procedures for existing and or developing programs/facilities.
- Serve as the Quality administrator for lot release of Necator americanus hookworm larvae for use in clinical trials, performing review of manufacturing records and quality control data.
- In coordination with other operational groups (e.g., MITM Clinical Immunology Lab, MITM Parasitology Lab, GW MFA), support initiatives that contribute to a continual state of inspection readiness for clinical trial programs.
- Contribute to FDA regulatory submissions, annual reports, and clinical study reports.

Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a BA/BS in a related discipline plus 5 years of relevant professional experience. Degree must be conferred by the start date of the position.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Preferred Qualifications:

- Experience in clinical research or laboratory, supporting GxP processes and systems is preferred.
- Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials.
- Ideal candidate will have broad experience in basic clinical and/or laboratory operations, compliance principles in GCP, GLP and/or GMP, strong attention to detail and solid organizational skills.

Typical Hiring Range $61746 - $90253 How is pay for new employees determined at GW? II. POSITION INFORMATION

Campus Location: Foggy Bottom, Washington, D.C. College/School/Department: School of Medicine and Health Sciences (SMHS) Family Research and Labs Sub-Family Centers/Institutes Stream Individual Contributor Level Level 3 Full-Time/Part-Time: Full-Time Hours Per Week: 40 Work Schedule: Monday through Friday, 8:30 to 5:30 Position Designation: Essential: Employees who perform functions that have been deemed essential to maintaining business or academic operations. Employees are generally expected to work from home during an event and may be asked to physically report to work. Telework: Required Background Check Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search Special Instructions to Applicants: Internal Applicants Only? No Posting Number: R000716 Job Open Date: 01/29/2019 Job Close Date: If temporary, grant funded or limited term appointment, position funded until: Background Screening Successful Completion of a Background Screening will be required as a condition of hire. EEO Statement:

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

Applicant Documents Required Documents
  1. Curriculum Vitae
  2. Names and Contact Information for References
Optional Documents
  1. Cover Letter

Organization

GWU pic1George Washington University is a top nationally recognized institution and is currently the largest employer of higher education in the District of Columbia with students and faculty from all 50 states and more than 120 countries. Our community is as diverse as the many backgrounds and occupations we represent. Enrichment, opportunities, and work/life balance are just some of the rewards of joining our learning community. The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law. Successful Completion of a Background Screening will be required as a condition of hire.

The George Washington University is a dynamic institution located in the heart of Washington, D.C. As the largest institution of higher education in the nation’s capital, GW is able to draw upon a rich array of resources to enhance its educational endeavors and generate creative energy. Through its diverse students, faculty, staff, and alumni, the university contributes talent and knowledge to improve the DC area and the world.

Located four blocks from the White House, GW is the largest institution of higher education in the nation's capital. The university offers comprehensive programs of undergraduate and graduate liberal arts study as well as degree programs in medicine, law, engineering, education, business, and international affairs.

The George Washington University dedicates itself to furthering human well-being. We value a dynamic, student-focused community stimulated by cultural and intellectual diversity and built upon a foundation of integrity, creativity, and openness to the exploration of new ideas. A diverse population of undergraduate, graduate, and professional students from all 50 states, D.C, and more than 130 countries enroll at GW each year. 

To promote the process of lifelong learning from both global and integrative perspectives, the university provides a stimulating intellectual environment for its diverse students and faculty. By fostering excellence in teaching, GW offers outstanding learning experiences for full-time and part-time students in undergraduate, graduate, and professional programs in D.C., the nation, and abroad. The university acts as a catalyst for creativity in the arts, the sciences, and the professions by encouraging interaction among its students, faculty, staff, alumni, and the communities it serves.

GWU profile pic2What Makes GW a Great Place to Work

Working at GW is an experience that allows each individual an opportunity to grow both personally and professionally. Our community includes individuals of diverse and unique backgrounds whose individual contributions build the momentum to make GW a great university and indeed, a great place to work. As a top employer, we want to do all we can to attract the best people who connect to our mission of excellent teaching, research, and community engagement. Those who are here are “Proud to be GW.”

GW is committed to offering its employees a comprehensive benefits package including health and welfare plans such as medical, prescription, dental, vision, flexible spending accounts and life and disability insurance as well as retirement and tuition programs. Free wellness programs include exercise classes, walking clubs, smoking cessation benefits, free flu vaccinations, GW’s Healthy Pregnancy Program, a faculty and staff summer softball league, and much more.

Company info
Website
Telephone
202-994-8500
Location
2013 H Street
Washington
DC
20006
United States

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