The Manager of Human Research Protections (HRP) assumes a critical role in the research enterprise at SLUHN. The primary responsibility is to ensure that all human subject research conducted under its auspices is carried out in such a manner that the rights and welfare of participants in research studies are protected and that SLUHN is in compliance with institutional, state and local, and federal regulations. Specific responsibilities will include management and supervision of staff assigned to provide administrative and regulatory support to the IRB and the development of a formal Human Research Protections Office (HRPO), ensuring efficient and high quality performance.
JOB DUTIES AND RESPONSIBILITIES:
Demonstrate clear high-level knowledge and practice of ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPPA Regulations and Confidentiality Policy, and IRB policies related to human subject protection and clinical research in general.
Assess current research state and drive strategic plan to support future growth as it pertains to human research protection, to include resource and FTE needs, programmatic needs such as internal audit and data and safety monitoring, and necessary compliance initiatives.
Provide regular feedback to the Senior Network Director of Clinical Trials and Research on such assessments and needs.
Manage HRPO and IRB staff in regards to IRB & SLUHN policy, workflow efficiency, record-keeping, administrative issues, job performance, interaction with investigators, interpretation of human subjects regulations, management of IRB meetings and IRB member issues. This includes interviewing, hiring, evaluating performance, and terminating as necessary, as well as assessing overall resource needs. Serve as a voting member of the SLUHN IRB, attend Pre-IRB meetings, and act as resident expert on human subject regulations, policy interpretation and implementation. Serve as primary resource to the SLUHN research community and research-related offices concerning interpretation and application of federal, state, and local human subject regulations, IRB policy and procedures, preparation and submission of IRB applications, reporting of adverse events, informed consent procedures, privacy issues, protocol violations, overall IRB issues, etc.
Develop and implement an internal quality assurance program with necessary reporting mechanisms and action plans for non-compliance, including monitoring QA audits and reviewing QA audit reports.
Investigate issues of non-compliance and research misconduct, create documentation and correspondence as necessary, communicate findings of non-compliance/misconduct to institutional officials and federal authorities as appropriate, and serve as a member of all non-compliance/misconduct hearings that involve human subjects.
Design and implement a human research training program for IRB members with ongoing education. Implement the web-based NIH human subject research training program to be required for all SLUHN researchers.
Oversee and maintain all HRPO Policies and Procedures in line with all regulations.
PHYSICAL AND SENSORY REQUIREMENTS: Requires sitting for up to seven hours per day, 4 hours at a time. Standing for up to 4 hour per day, 3 hours at a time. Requires occasional fingering, handling and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. At times requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.
TRAINING AND EXPERIENCE: Required: Knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions. Must have experience with electronic IRB systems or a CTMS. CIP certification and a minimum of 3 years of directly related experience required.
EDUCATION: Bachelor’s degree (Master’s degree preferred) and CIP certification with a minimum of 3 years directly related experience required. Must have high-level working knowledge of medical and research terminology, and research regulations.
St. Luke’s University Health Network (SLUHN) is a non-profit, regional, fully integrated, nationally recognized network providing services at seven hospitals and more than 200 sites, primarily in Lehigh, Northampton, Carbon, Schuylkill, Bucks, Montgomery, Berks and Monroe counties in Pennsylvania and in Warren County, New Jersey