The HRPP Administrator provides administrative support and oversight to core components of the institution's HRPP including Training and Education, Quality Assurance and Improvement, IRB Reliance processes, and other researcher initiatives involving human participants or human data or biospecimens. Oversees the HRPP/IRB Office, charged with the facilitation and support of research involving human subjects reviewed by BRANY, and other IRBs to which review is ceded by NJH (e.g., required under NIH sIRB Policy, in accordance with the SMART IRB initiative, etc.), as well as administration and documentation of human research determination and exemption requests on behalf of the Institution.
Develops and implements a training and education program that meets the initial and continuing needs of researchers in the compliant conduct of research, and responsibilities associated with conducting research oversight by an external IRB.
Serves as principal point of collaboration, leadership & expertise to both internal HRPP stakeholders (e.g., Grants and Contracts Office, National Jewish Health Pharmacy, Privacy Officer, Institutional Biosafety Committee, Corporate Compliance Office) and external constituencies on professional and operational matters pertaining to the HRPP.
Reviews and documents requests for human research and exemption determinations.
Develops and implements a post-approval monitoring program for active NJH research activities; use results to affect educational topics for researchers.
Serves as the reliance administrator for IRB reliance requests, in accordance with NJH HRPP SOPs.
Interprets and applies federal, state and local regulations, policies and procedures related to research involving human participants. Works closely with Institutional leadership to ensure compliance with the ethical and regulatory requirements for human subject’s research.
Maintains periodic communications with researchers regarding new/updated policies and guidance, and reminders regarding the compliant conduct of research.
Establishes, documents, and implements short-and long-range goals, objectives, policies and operating procedures based on observed needs of the HRPP; monitors and evaluates operational effectiveness and affect changes required for improvement; provide feedback to the Institutional Official/Designee, and the researchers as appropriate.
Provides advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and Institutional laws, regulations, and guidance’s.
Works closely with Institutional leadership to ensure compliance with the ethical and regulatory requirements for human subject’s research.
Work Experience: A minimum of 5 years of research experience involving human subjects research required.
Special Training, Certification or Licensure: Certified IRB Professional (CIP) or other appropriate certification as a research professional required
Internal Number: 13315
About National Jewish Health
National Jewish Health is a non-profit, non-sectarian institution and is a longstanding cornerstone in the Denver healthcare community. National Jewish Health seeks to attract the best-qualified candidates who support the mission, vision and values of the Institution and those who respect and promote excellence through diversity. We are committed to providing equal employment opportunities (EEO) to all employees and applicants without regard to race, color, creed, religion, sex, age, national origin, citizenship, sexual orientation, gender identity and expression, physical or mental disability, marital, familial or parental status, genetic information, veteran status or any other legally protected classification. We are a tobacco and fragrance free environment.