Executive Director Research Regulatory Affairs - CNRI

3 days left

Silver Spring, Maryland-Silver Spring
Feb 04, 2021
Mar 11, 2021
Full Time
Reporting to the Vice President of Research Administration, the Executive Director of Research Regulatory Affairs promotes a culture of compliance and works in close collaboration with the Vice President of Finance & Faculty Administration, the Chief Compliance Officer, the Chief Academic Officer and the Chief Research Officer. Responsibilities include working in tandem with the Chief Compliance Officer and Children's National Research Institute (CNRI) Leadership on the development and implementation of the Children's National Hospital's (CNH) Research Compliance Program (the "Program") and strategizing with CNH leadership to minimize institutional compliance risk. The Executive Director of Research Regulatory Affairs also works closely with operations and the Research Integrity Officer (RIO) and IRB, IACUC and IBC Chairs to promote a culture of compliance across the research enterprise.

The Executive Director oversees the operations of the Office for the Protection of Human Subjects (OPHS)/institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC), the Post-Approval Quality Assurance Program and is responsible to ensure compliance with mandated education and training programs in these areas. The position has an integral administrative role in facilitating research integrity at all stages of research (pre-study stage, active-study stage, post-study stage), and ensures compliance with applicable federal and local laws and regulations, and adherence to professional and ethical standards as well as institutional policies and procedures. These include but are not limited to GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GSP (Good Safety Practice), and GMP (Good Manufacturing Practice).

The Executive Director is responsible for the oversight, administration, and coordination of all fiscal, human resources, administrative, and the development of educational programs of the regulatory committees (IRB, IACUC, IBC) as well as the research QA Program with the goal to: (1) improves the safe and efficient conduct of research, (2) reduce the administrative burden by improving operational efficiency, and (3) accelerate protocol review and decision making turnaround time by improving review practices.

The Executive Director develops policies and procedures (P&Ps) and ensures that appropriate stakeholders are trained in P&Ps and follow them. This position includes responsibility for protocol review and approval and regular interaction with IRB, IACUC and IBC Chairs, investigators and their research teams. The Executive Director assumes leadership over the functional maintenance of all electronic review system and integration with other research infrastructure IT system. The Executive Director participates in FDA, USDA , NIH and other regulatory site inspections and sets priorities for internal audits with leadership for the research compliance program staff.

The Executive Director oversees the AAHRPP and AAALAC accreditation renewals and has the responsibility for the accreditation status to remain in good standing. The position also oversees the post-approval QA Program, with a focus on performing comprehensive audits and monitoring of Investigator-initiated clinical trials conducted under a Food and Drug Administration (FDA) IND/IDE, and other high-risk protocols as necessary.

The individual is responsible for planning, coordination, control, and continuous improvement of processes and methods to conform to internal and external quality standards at Children's National and directs quality assurance and compliance functions. The individual will develop a program to conduct audits and monitoring visits to determine compliance with approved protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) or other applicable regulatory requirements. Together with Senior Management team the individual implements a quality assurance/regulatory strategy for the institution to ensure compliance with all applicable regulatory requirements and makes recommendations to Senior Management and Leadership regarding the specific activities and resources required to support this strategy. The individual is responsible for developing and implement a detailed audit plan and SOPs, managing the internal auditing functions and developing training programs, consistent with organizational needs and in accordance with national and international requirements. The Executive Director serves serves on Conflict of Interest and Research Compliance committees and represents CNH with professional organizations in this area.


Minimum Education
Bachelor's Degree (Required).
Master's Degree (Preferred).

Minimum Work Experience
10 years of combined applicable clinial research compliance and accreditation and regulatory affairs in research experience.
Demonstrated experience in leading institutional compliance programs.
Proficient knowledge of accreditation standards, applicable federal regulations, and policy formulation experience required (Required).

Required Skills/Knowledge
  • Highly effective verbal, written and interpersonal communication skills to communicate effectively with all levels of leadership faculty, trainees and staff.
  • Comprehensive understanding of the operation of the regulatory framework and of compliance, and their role in supporting financial and research performance outcomes with focus on clinical research.
  • Documented knowledge of Code of Federal Regulations (CFRs), local and applicable international regulations.
  • Ability to analyze and resolve problems that affect research compliance programs.
  • Ability to work collaboratively with others in the organization to build open and trusting relationships designed to achieve research compliance goals consistent with the values and mission of the organization.
  • Ability to create, develop, and implement educational programs.
  • Experience in responding to crises situations such as unscheduled review/audits and investigations conducted by government and/or accreditation agencies.
  • Demonstrated ability to effectively communicate legal and regulatory issues affecting the research enterprise.
  • Must possess a personal presence that is characterized by a sense of honesty, integrity and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals and values of the organization.

Functional Accountabilities

Responsible Conduct of Research
1. Ensure compliance with standards for the responsible conduct of research, research ethics and integrity, safety and compliance, including data security, privacy, confidentiality and human subjects protection.
2. Plan, conduct, and manage audits within the federal, local and institutional regulations, policies and procedure, guidelines and standards.
3. Assist research teams with the timely filing of regulatory documents and monitor compliance with relevant laws and regulations.
4. Responsible for appropriate use of research funds and resources.
5. Ensure compliance with all annual training requirements.
6. Maintain professional growth and development and enhance quality improvement initiatives and regulatory compliance through seminars, workshops, and professional affiliations to keep abreast of the latest trends in field of expertise.
7. Partner with the Chief Compliance Officer, RIO and organizational leaders to foster a culture of compliance and the development and implementation of action plans in preparation or response to external or internal audits.

Program Administration
1. Lead and partner with others in the development, implementation and ongoing refinement of the clinical and research regulatory compliance program.
2. Oversee the operation of the IRB, IACUC and IBC and establishes performance metrics and ongoing process improvement programs.
3. Oversees the post approval auditing and monitoring program, including any action plans and/or commitments made by leadership.
4. Review the content and performance of the compliance policies and procedures, on a routine basis
5. Provide oversight, direction and consultation to ensure that CNH meets all clinical and research regulatory requirements as mandated by all internal programs as well as organizational and external agency accreditation standards.
6. Organize, direct, and integrate practices to assure continued compliance with State and Federal laws.
7. Participate in site review by State, Federal, or other regulatory agencies.
8. Report on on the compliance program and performance metrics.
9. Oversee the development, implementation and maintenance of an effective compliance communication and training program for the research enterprise
10. Develop budgets and ensure that program consistently meets finance and performance targets.

Education Program & P&P Development
1. Stay current with regulatory, quality, and industry trends related to regulatory compliance.
2. Draft, revise, and update SOP's, P&P and develop related educational programs and training
3. Ensure compliance with required regulatory training requirements and take action in regards to non-compliance as defined by institutional officials.
4. Serve on institutional Research Compliance, COI and P&P Committees.
5. Develop quality and risk assessment tools and reports.
6. Perform cause analysis to identify source of problems of non-compliance.
7. Oversee department training and development including identification of training needs.
8. Develop training programs in partnership with the CTSI-CN, the RIO and leaders of other strategic initiatives.
9. Maintains subject matter expertise through training (internal and external), represent the Program at national forums.

Human Research Management
1. Establish, and maintain an organizational structure and staffing to effectively accomplish the organization's goals and objectives; manage recruitment, training, supervision, and evaluation of staff.
2. Directly supervise management including: supervision, training, mentorship and evaluation of the staff, and providing coverage when needed.
3. Serve as a mentor to others and partner in their professional development.
4. Define, set and utilize appropriate performance and quality measures for staff.
5. See oneself as a leader of others, demonstrate commitment to continuing professional education and hold the team members accountable individually and as a group for results.
6. Establish, build and sustain professional contacts for the purpose of building networks of people with similar goals that support similar interests.

Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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