Clinical Research Quality Assurance Program Manager/Auditor
Children's National Medical Center
October 3, 2018
Full Time - Experienced
CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional), RAC (Regulatory Affairs Certification), RQAP-GCP (Registered Quality Assurance Professional – GCP)
4 Year Degree
Reporting to the Vice President of Research Administration, the Clinical Research QA Program Manager/Auditor manages the Clinical Research QA Program, with a focus on performing comprehensive audits of Investigator-initiated clinical trials conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND)/Investigational Device Exemption (IDE), and other high-risk protocols as necessary. The individual is responsible for planning, coordination, control, and continuous improvement of processes and methods to ensure conformance to internal and external quality standards at Children's National and directs quality assurance and compliance functions. The individual will perform extensive audits to determine compliance with IRB approved protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. Together with Senior Management 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 implementing a detailed audit plan and SOPs, managing the internal auditing functions and developing training programs consistent with organizational needs and in accordance with current international GCP requirements. The individual serves as an internal resource to principal investigators and research teams, providing guidance with IND/IDE submissions, and partnering with others on developing a comprehensive clinical research regulatory and support infrastructure. The position serves on committees and represents the program with professional organizations.
Requirements for this position include a Bachelor’s degree. Completion of an accredited Nursing (RN), Physician Assistant (PA), or Bachelor's Degree in a related healthcare field are preferred and/or extensive clinical research experience.
Minimum Work Experience
Requires a minimum of 5-6 years of clinical research experience in the pharmaceutical, medical device, biotechnology or contract research industry. Experience should include a minimum of 4 years experience in quality assurance/regulatory affairs, auditing, clinical research monitoring, data management or other relevant area, including 3-4 years of applicable GCP, compliance and auditing experience. It requires knowledge of GCP and ICH regulations and auditing techniques. Excellent communication and organizational skills with superb attention to detail.
Experience with MS Office products and database applications required.
Excellent inter-personal skills and customer service focus is required.
Demonstrated ability to manage multiple projects and staff under varying time constraints.
Strong writing skills.
Specific Requirements and Preferences
Experience in clinical research management and oversight, including project management in a dynamic research setting.
Experience in developing and implementing training/education.
Management experience. Strong organizational, negotiation, interpersonal, verbal and written communication skills, with attention to detail.
Experience working with pharmaceutical and FDA agency representatives.
Demonstrated communication, leadership, and team building skills. Evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others.
Additional Salary Information: Commensurate with experience
Internal Number: 180002B1
About Children's National Medical Center
Children’s National Health System, based in Washington, DC, has been serving the nation’s children since 1870. Children’s National is Magnet® designated, and was ranked among the top 10 pediatric hospitals by U.S. News & World Report 2015-18. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is one of the nation’s top NIH-funded pediatric institutions. With a community-based pediatric network, seven regional outpatient centers, an ambulatory surgery center, two emergency rooms, an acute care hospital, and collaborations throughout the region, Children’s National is recognized for its expertise and innovation in pediatric care and as an advocate for all children.Mission StatementAs the nation’s children’s hospital, the mission of Children’s National Medical Center is to excel in Care, Advocacy, Research and Education.We accomplish this through:•Providing a quality health care experience for our patients and families.•Improving health outcomes for children regionally, nationally, and internationally.•Leading the creation of innovative solutions to pediatric health challenges.