Research Quality Assurance Program Director

Sep 15, 2021
Oct 20, 2021
Full Time
Children's National Hospital (CNH) is ranked as one of the top 10 pediatric hospitals in the nation - with the #1 ranked neonatology program - by U.S. News & World Report for the fifth year in a row and ranked #11 in the world in Newsweek's World's Best Specialized Hospitals of 2022. Children's National Research Institute leads innovation by conducting and promoting translational and clinical medical research programs that lead to improved understanding, prevention, treatment and care of childhood diseases.

The CNH research portfolio is growing rapidly and requires an experienced leader to develop and implement a team of monitoring/auditing professionals for the CNH quality assurance efforts.The CNH research portfolio is growing rapidly and requires an experienced leader to develop and implement a team of monitoring/auditing professionals for the CNH quality assurance efforts.

Reporting to the Executive Director of Research Regulatory Affairs, the Research QA Program Director will be responsible for all aspects of Children's National Research Institute Quality Assurance/post-approval monitoring (PAM) activities to ensure quality assurance and compliance of Children's National Hospital-sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Children's National Policies and Procedures, Standard Operating Procedures (SOPs) and current industry standards and practices. Activities will generally fall under the following areas: GCP QA monitoring and audit program, QA and compliance oversight for all clinical research activities and internal clinical research study team support and education/outreach in regard to IND/IDE Sponsor-Investigator clinical trial FDA inspection readiness. The Program Director will establish, maintain and ensure the effectiveness of quality assurance programs and documentation to maintain GCP compliance and inspection readiness, with a focus on performing comprehensive audits and monitoring of investigator-initiated clinical trials that are subject to Food and Drug Administration (FDA) IND/IDE requirements and other high-risk studies. The Program Director is responsible for the planning, coordination, oversight and continuous improvement of processes and methods to ensure conformance to internal and external quality standards at Children's National Hospital, and directs quality assurance and compliance functions. In coordination with senior management, the individual implements a quality assurance/regulatory strategy for the institution to ensure compliance with all applicable regulatory requirements by making recommendations to leadership regarding the specific activities and resources required to support this strategy, implementing an annual post-approval monitoring plan (including policies and SOPs), managing the internal audit functions and developing training programs and tools consistent with organizational needs in accordance with current regulatory framework governing clinical research, including FDA/federal inspection readiness and IND/IDE submission resources. The individual will partner with other Children's National central research offices to develop a robust clinical research regulatory and support infrastructure. The position also serves on institutional committees and represents the program with professional organizations.

The position is 50% remote and 50% onsite to monitor QA activities at Children's National Hospital, 111 Michigan Ave, NW, Washington, DC 20010.


Minimum Education
Bachelor's Degree Bachelor's Degree in a scientific, medical or regulatory discipline (Required)
Master's Degree Master's degree in related discipline. (Preferred)

Minimum Work Experience
5 years Requires a minimum of 5 years of experience in an academic biomedical research, research hospital, pharmaceutical, biotechnology or contract research (CRO) setting, including a minimum of 4 years in quality assurance/regulatory affairs, GCP/GMP auditing, clinical research monitoring, data management or other relevant oversight area. Prior experience with IND/IDE Sponsor Investigator studies desired. (Required)

Required Skills/Knowledge
Management experience, with the ability to develop and lead a team of regulatory professionals and collaborate with peers in central senior research administration to develop research regulatory support structure.
Advanced knowledge of GCP and ICH regulations and auditing techniques.
Experience in clinical research management and oversight, including project management in a dynamic research setting, managing multiple institution-specific projects under varying timelines while communicating with the FDA and other regulatory entities.
Experience developing and implementing training, education and outreach activities.
Strong interpersonal, verbal and written communication skills and attention to detail.
Experience with MS Office applications.
Strong leadership skills with demonstrated ability to interface with senior leaders and different levels within the organization.
Experience working with pharmaceutical and FDA/federal representatives.

Required Licenses and Certifications
Quality Assurance Certification (Preferred)
Clinical Research or Clinical Research Auditing (Required)

Functional Accountabilities
Responsible Conduct of Research Oversight
  • Ensures 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.
  • Uses research funds and resources appropriately.
  • Ensures compliance with all annual training requirements.
  • Maintains professional growth and development and enhances quality improvement initiatives and regulatory compliance through seminars, workshops and professional affiliations in order to keep abreast of the latest trends in field of expertise.
  • Partners with compliance and research program staff and central research offices to foster a culture of compliance and the development and implementation of action plans in preparation for or response to external or internal audits

QA Audits
  • Plans, conducts and manages audits within federal, local and institutional regulations, policies and procedures, guidelines and standards.
  • Assists research teams with the timely filing of regulatory documents (e.g. IND reports to FDA) and monitors compliance with relevant laws and regulations.
  • Follows up as appropriate to obtain audit response and reviews responses to audit findings for appropriateness and completeness.
  • Assists research teams in planning and preparing for external audits.
  • Conducts audit debriefs with project teams and/or QA Program leadership as required.
  • Prepares written audit reports, communicates findings and recommendations and evaluates the adequacy and completeness of corrective and preventative action plans.
  • Reviews external quality review reports with all findings of non-compliance and recommendations.
  • Reviews and discusses the final report with the PI and study team.
  • Assists the PI and study team in developing and creating an effective Corrective and Preventive Plan (CAPA).
  • Provides the Executive Director with a final audit report of non-compliance and CAPA .
  • Ensures that the required number of audits are conducted each quarter, directing staff and support team members as needed.
  • Conducts non-routine quality assurance audits of clinical research.

QA Program Management
  • Oversees the daily operations of the Research QA and Post-Approval Monitoring program, which includes leading continuous process improvements within the quality assurance program, tracking program metrics and developing QA benchmarks.
  • Maintains institutional database of all IND/IDE submissions and external FDA and sponsor audits and provides reports as requested.
  • Coordinates the QA Program Executive Committee.
  • Collaborates with principal investigators and research teams on audit findings, corrective action and preventive plans
  • Works with QA Leadership to provide feedback, deficiencies and common trends identified in audits in order to ensure timely and effective change control to improve overall quality.
  • Facilitate regulatory inspections
  • Develop quality and risk assessment tools and checklists
  • Analyze and propose best practices for implementing and conducting audits and investigations
  • Participate in inspection readiness plans and activities
  • Continuously validate and verify information needed for decision making or documentation
  • Ensures with QA leadership that the implemented research audit program is appropriate in scope, that identified issues are corrected and educational programs are available for investigators and research staff.

Education Program & P&P Development
  • Stays current with regulatory, quality and industry trends related to GCP
  • Drafts, revises and updates quality assurance SOP's, P&P and other QA documents
  • Serves as a mentor to and provides feedback for other QA auditors and coordinators.
  • Develops quality and risk assessment tools and checklists
  • Performs cause analysis to identify sources of problems or non-conformances.
  • Partners and coordinates with the OPHS education manager to assess institutional training needs, oversee department training and develop training programs
  • Maintains subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines and regulations, etc.

Human Resource Management
  • Maintains established organizational structure and staffing to effectively accomplish the organization's goals and objectives; manages recruitment, training, supervision and evaluation of staff.
  • Directly supervises clinical research audit staff, which includes directing day-to-day supervision, training, mentorship and evaluation of the staff, and providing coverage when needed.
  • Defines, sets and utilizes appropriate performance and quality measures.
  • Sees oneself as a leader of others, demonstrates commitment to continuing professional education and career development for staff and holds team members accountable individually and as a group for results.

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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