Quality Assurance Specialist - Office of Human Subjects Protections - Georgetown University

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Requirements

Quality Assurance Specialist - Office of Human Subjects Protections - Georgetown University

The Quality Assurance Specialist oversees all audits conducted by the Office of Research Quality Assurance (ORQA) , conducts internal study audits (cause and not for cause), and assists in compliance and quality assurance training, as well as the development of ORQA policies. Reporting to the Senior Director, Office of Human Subjects Protections (OHSP), they have responsibilities that include but are not limited to:

• Conduct internal study audits for compliance with institutional and regulatory requirements regarding clinical research; and review informed consent documents, all source documentation and case report forms for adherence to good clinical practice, and other regulatory documents needed for the accurate and compliant implementation of the study protocol and procedures.
• Review study-related processes to assure adherence with applicable requirements, including but not limited to the approved study protocol, Georgetown University policies, the approving Institutional Review Board (IRB), and applicable Food and Drug Administration (FDA) and other regulatory requirements; and verify that regulatory files maintained for the study are complete and accurate.
• Manage document auditing activities in writing, using appropriate report formats and communicate such findings to the Senior Director for dissemination to study teams and any other applicable parties identified by the Senior Director.
• Maintain, in strict confidence, all confidential information regarding research studies and clinical research study team activities and members; assist the Senior Director and Georgetown University Medical Center Research departments with the development of compliance and operational policies and procedures; and represent Georgetown University in sponsor audits, assist in assuring compliance with sponsor corrective action requirements, and assist GU study teams in preparing for government regulatory inspections. 
• With guidance and assistance from the Senior Director, conduct focused compliance training with PIs on an annual and as-needed basis; develop and remain well versed in research websites, journals and government publications to keep abreast of new regulations related to clinical research; report any instances of non-compliance discovery in internal audits; and share audit data for tracking and reporting purposes with Senior Director, OHSP.
• Demonstrate support for compliance in the performance of job duties and responsibilities by developing and maintaining knowledge of - and performing job functions in compliance with - rules, regulations, policies and status that affect their job; and maintain knowledge of - and perform job functions in compliance with - GU policies and procedures; and report compliance concerns in an appropriate and timely manner.

Qualifications

• Bachelor’s degree in Health Sciences, Health Systems or a related field.
• 5 years of clinical research experience [note: consideration will be given to an equivalent combination of work experience and relevant education and a strong understanding of FDA, ICH and other regulatory and audit issues in clinical trials and compliance]
• An understanding of medical terminology and technical writing
• Excellent interpersonal communication, including oral and written
• Proficiency with Microsoft Office
• The ability to learn software programs - e.g. , IRB, CTMS, EMR

Preferred qualifications

• Research monitoring experience
• Certification as a CCRA or CCRP

Work Mode: On Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources Mode of Work Designation .

Current Georgetown Employees:

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here  for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or [email protected] .

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website .

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer  fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law .

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website .

COVID-19 Vaccination Requirements:

The Georgetown University community is committed to our public health approach and the important role that vaccines play in contributing to the safety of our University and our broader communities. Georgetown University requires students, faculty, staff and visitors to be fully vaccinated against COVID-19 and to have received a COVID-19 vaccine booster shot when eligible, or to have an approved medical or religious exemption. This requirement applies to all faculty and staff, including teleworking employees. Complete details and updates can be found in the Coronavirus (COVID-19) Resource Center .