The Manager of Human Research Protection Program (HRPP) assumes a critical role in the research enterprise at Baystate Health (BH). 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 Baystate Health complies with institutional, state and local, and federal regulations. Specific responsibilities will include reporting to and working with the Director of Healthcare Research Compliance/Chief Research Compliance Officer overseeing the daily operations of the BH Institutional Review Board (IRB) office and serves as a liaison between the board and the research team. Management and supervision of staff assigned to provide administrative and regulatory support to the IRB and the HRPP staff responsible for Education and Compliance in the Human Research Protection arm, ensuring efficient and high quality performance.
What You Will Do:
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. Including but not limited to provide regular feedback to the Director of Healthcare Research Compliance/Chief Research Compliance Officer on such assessments and needs.
Manage HRPP and IRB staff in regards to HRPP & Baystate Health policy, workflow efficiency, record-keeping, administrative issues, scheduling and earned time request, interaction with investigators, interpretation of human subjects regulations, management of IRB meetings and IRB member issues. This includes participating in interviewing, hiring, evaluating performance, and terminating as necessary.
Serve as a resource to the voting members of the Baystate Health IRBs, attend IRB meetings, and provide consistent interpretation on human subject regulations, policy and implementation. Serve as resource to the Baystate Health research community and research-related offices concerning interpretation and application of federal, state, and local human subject regulations, HRPP policy and procedures, preparation and submission of IRB applications, reporting of adverse events, informed consent procedures, privacy issues, protocol violations, overall IRB issues.
Working with the Director of Healthcare Research Compliance to oversee 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 as assigned, create documentation and correspondence as necessary, communicate findings of non-compliance/misconduct to institutional officials and federal authorities as appropriate.
Assist in re-design and implementation of a human research training program for IRB members with ongoing education. Including maintenance of CITI program requirements. Provide suggestions on the maintain of all HRPP Policies and Procedures in line with all regulations.
Participate in the process for re-accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) as needed. Providing information for annual reports, maintenance, coordinate sight visits and reaccreditation applications as required.
Work under minimal supervision of the Director to faciliate Application for Massachusetts Controlled Substances Registration to Use Controlled Substances and Investigational New Drugs in Research, MA General Law, Chapter 94C.
Facilitate ongoing collaboration between researchers, IT, constituents conducting internal processing of research, and external clients to create an infrastructure that supports research growth and diversity.
Develop, recommend, and continuously improve policies, procedures, and strategies to streamline workflow of research compliance operational processes and ensure stakeholder objectives.
Maintain and measure project performance by maintaining timelines and by using tracking/analysis tools. Analyze complex data, draw meaningful conclusions, and report conclusions in a clear, understandable format to all stakeholders at all levels.
What You Will Need:
Minimally Required Education: Bachelor's Degree
Preferred Education: Master's Degree
Minimally Required Experience: Bachelor's degree and five or more years of relevant experience, or combination of education and relevant experience.
Skills / Competencies:
Excellent customer service skills and ability to use tact and discretion.
Strong leadership and management skills.
Expert knowledge of regulatory information regarding the use of human participation in research and teaching.
Demonstrated understanding of the principles of human research protection standards.
In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
Advanced knowledge of human subjects protection regulations and best practices, as evidenced by certification (e.g., Certified IRB Professional).
Certification: Certified IRB Professional (CIP) is required
Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.
Internal Number: 83911
About Baystate Health
Baystate Health, a leading not-for-profit integrated health system, is transforming the delivery of health care to the communities it serves. Baystate Health (BH) is one of New England’s leading and largest integrated healthcare systems, serving more than 800,000 people throughout Western Massachusetts. With about 12,000 employees, a 1,200-member medical staff, and net patient service revenue of more than $2.3 billion, this dynamic and growing system includes an academic medical center, a children’s hospital and three community hospitals. It also includes a large multispecialty group, (Baystate Medical Practices), Baystate Home Health, Baystate Reference Laboratories, and Health New England, a 205,000-member health insurance company.