Director, Human Research Protections at The George Washington University

I. JOB OVERVIEW

Job Description Summary:

The Director, Human Research Protections reports to the Associate Provost Research Integrity & Compliance (AP-RIC) and is responsible for leading the administrative, regulatory, and programmatic activities supporting the university’s Human Research Protection Program (HRPP). The Director, Human Research Protections works closely with Office of Research Integrity & Compliance (ORIC) leadership, the Office of Clinical Research (OCR) staff, the Office of General Counsel (OGC), regulatory committee Chairs and members, and others in the GW research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact the research enterprise. In the performance of duties, the position will review, research, and interpret changes, trends and new developments related to areas of oversight; provide written analysis on specified topics; draft policies and procedures to implement and operationalize related initiatives; ensure regulatory review processes are standardized; develop strategies to enable implicated research departments and personnel to successfully adapt to changes; serve as a resource to the GW community regarding research matters in areas of oversight; maintain staff productivity; and resolve compliance, service and operational issues.

The Director, Human Research Protections position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives. In addition, this position is accountable for employee engagement, adequate staffing levels, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment. This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations.

Responsibilities:

• Provides strategic leadership and operational direction to the Office of Human Research (OHR) staff.
• Oversees the administrative, regulatory, and programmatic activities of the Institutional Review Boards (IRB).
• Serves as Human Protections Administrator (HPA) on GW’s Federal Wide Assurance (FWA).
• Ensures a thorough review of research protocols prior to submission to the regulatory committees for review. Ensures administrative teams are appropriately trained to provide comments to the applicable regulatory committees for consideration with submissions to assure that the review is conducted according to regulations and guidance.
• Facilitates the submission of the Association of Accreditation of Human Research Protection Programs (AAHRPP) accreditation application within one year of hire.
• Serves as a key contact in communications with regulatory agencies and accrediting bodies.
• In collaboration with the Executive Director, Research Integrity and Compliance, leads external agency inspections and audits; provides support for audits and inspections to investigators, administrative teams and regulatory committees (i.e. IRB). Reviews agency reporting letters, communications with regulatory authorities, and assists with responses to internal and external investigations, audits and other matters.
• Communicates with federal and accrediting oversight authorities and carries out annual reporting requirements.
• In collaboration with the Executive Director for Research Integrity and Compliance, oversees quality assurance and quality improvement initiatives, including post-approval monitoring research.
• Directs, develops, and implements strategic and operational/high level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives.
• Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service, and cost effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees.
• Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes.
• Identifies opportunities and takes action to build strategic relationships between areas of oversight, teams, schools & departments to achieve business goals.
• Drives the promotion of teamwork within and between schools/departments; participates and/or leads and facilitates department process improvements as needed.
• Provides expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization. Serves as liaison between researchers & research teams, department management, committees & leadership related to areas of expertise.
• Works with relevant GW offices to establish office web pages, newsletters, marketing pamphlets, and other tools (educational content in areas of oversight, etc).
• In collaboration with the Executive Director for Research Integrity and Compliance, develops, delivers, and maintains education and outreach programming for the committees and the research community in areas of oversight to ensure compliance.
• Oversees administrative management of protocols, ensuring staff alignment with requisite expertise; ensuring appropriate staff coverage for regulatory operations; Develops and maintains and enforces safety standards, policies, and standard operating procedures.
• Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines. Responsible for staff maintenance of credentials and competencies, per accrediting/ licensing agency and/or department guidelines as applicable.
• Employs a proactive approach in the optimization of safe and high-quality outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety and quality.

Performs other work-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 Bachelor’s degree in an appropriate area of specialization plus 8 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study plus 6 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:

Certified IRB Professional (CIP) or Certified IRB Manager (CIM), or certified within one year of hire

Preferred Qualifications:

• Progressive relevant experience in a federally funded research organization overseeing regulatory committee operations included direct experience involving biomedical research and clinical trials.
• Experience with AAHRPP accreditation process
• Experience managing electronic regulatory committee submission and review systems
• Proven ability to manage relationships with researchers, staff and regulatory agencies
• Experience in balancing regulatory compliance requirements against practical needs and limitations
• Ability to lead change
• Graduate degree, JD or PhD preferred 
• 5 years of management experience and 8 years of experience in human subjects’ research 

Hiring Range

$120,157.92 - $209,025.43

GW Staff Approach to Pay

Healthcare Benefits

GW offers a comprehensive benefit package that includes medical, dental, vision, life & disability insurance, time off & leave, retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit

II. JOB DETAILS

Campus Location:

Foggy Bottom, Washington, D.C.

College/School/Department:

Office Vice President of Research (OVPR)

Family

Research Administration

Sub-Family

Research Compliance

Stream

Management

Level

Level 3

Full-Time/Part-Time:

Full-Time

Hours Per Week:

40+

Work Schedule:

Monday – Friday, 8:30AM - 5:30PM

Will this job require the employee to work on site?

Yes

Employee Onsite Status

Hybrid

Telework:

Yes

Required Background Check:

Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search

Special Instructions to Applicants:

Employer will not sponsor for employment Visa status

Internal Applicants Only?

No

Posting Number:

S013552

Job Open Date:

01/23/2025

Job Close Date:

01/26/2025

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.