The HRPP Education & Compliance Specialist facilitates the proper conduct of human subjects research throughout Baystate Health. The position requires advanced knowledge of research regulations, guidance, and practice standards as well as the ability to apply this knowledge across a diverse portfolio of research. Responsibilities are divided into two broad categories: Education and Quality Assurance. The E&C Specialist develops and implements training and educational programs for investigators, research staff, and the Institutional Review Boards (IRBs); serves as an expert resource by providing mentoring and targeted support to investigators, IRB Chairs, members, and staff in the development, implementation, and oversight of research; and performs quality assurance monitoring of research protocol and IRB activities to ensure that the conduct and oversight of human subjects research is in compliance with regulations and in accordance with professional standards. This pro-active approach is intended to minimize risks to human subjects as well as regulatory risks at the investigator and institutional level.
Candidates for this position typically possess both a bachelor's and an advanced degree or professional certification, have extensive experience with human research, and highly developed interpersonal and communication skills. A clinical background is preferred. The E&C Specialist will be required to effectively communicate and report on complex topics with investigators and staff, board members, leaders, sponsor representatives, accrediting organizations, and federal regulating authorities and inspectors. Acute attention to detail is a necessity as well as the ability to interpret extensive and complex regulations and standards. The specialist is expected to actively participate in a variety of training opportunities as both an educator and as an attendee in order to update their knowledge base and to disseminate that knowledge throughout the organization.
Develop, implement, and refine the HRPP Quality Improvement/Assurance Plan. Perform routine compliance reviews of human subjects studies and IRB activities. Conduct directed (for-cause) reviews at the request of the Director, IRB, Research Integrity Officer (RIO) or Institutional Official (IO). Investigate allegations and findings of non-compliance. Report potential serious or continuing non-compliance with applicable regulations or institutional policies to the Director, IRB, and other leaders as appropriate. Provide Investigators with quality improvement recommendations to ensure that research is conducted in compliance with regulations, guidance, and practice standards. Prepare written reports detailing observations, regulatory risks, recommendations, and any other actions necessary to bring the research or IRB activity into compliance. Recommend action to the Director and IRB based on areas of concern identified during compliance reviews.
Assist investigators and the institution in preparations for external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities. Provide education on expectations and how best to prepare and organize materials and interact with the auditors or inspectors. Interview personnel and review records in advance to identify possible areas of concern so that the issues can be proactively addressed. Provide support and guidance to investigators and staff throughout the course of the audit or inspection. Attend entrance and exit interviews at the request of the Director. Assist in the development of corrective actions and written responses as warranted.
Develop, implement, and refine the HRPP Educational Plan. Coordinate with external vendors such as CITI, PRIM&R, and Saf-T-Pak to ensure that required trainings are available and up to date. Communicate requirements to the research community and track compliance. Develop and provide needs-based educational programs, trainings, and materials for the IRBs, investigators, and research staff. Interact and coordinate with other institutions to broaden available professional development opportunities through videoconferencing and other tools. Coordinate with Continuing Education to ensure availability of CMEs, CEUs, and other credits for educational offerings. Orient new investigators, IRB members, and research staff. Provide trainings on the electronic IRB submission system. Develop and make available study documentation and management tools for the research community.
Collaborate closely with investigators, research staff, and the IRB on the development and review of protocols and other applications. Provide expert guidance on the best approach to the various challenging issues that emerge during protocol development and implementation.
Develop system to track events and milestones for internal performance metrics and accreditation purposes. Provide regular reports to the Director on the above. Contribute to the development of reports and submissions to accrediting organizations and federal agencies. 10%
Facilitate monthly committee meetings with clinical research staff. Develop agenda and distribute materials.
Contribute to website development and maintenance to ensure that research community and IRB members have access to essential information and tools.
Attend IRB meetings, serve as an educational resource during the meetings, apply the knowledge gained by observing the board deliberations to aid researchers in developing successful submissions.
Attend conferences, meetings, and other educational opportunities in order to gain insight into new issues pertaining to human subjects regulations and practice standards subject to the approval of the Director and within budgetary constraints.
Required Work Experience:
1) 5 years experience in research, research compliance, or IRB administration
Preferred Work Experience:
1) 7 plus years experience in research, research compliance, or IRB administration
Skills and Competencies:
Facile with variety of electronic platforms including Word, PowerPoint, Excel, and electronic submission systems
Excellent interpersonal skills
Ability to successfully manage multiple simultaneous complex projects
Expert knowledge in research regulations and professional standards and ability to apply this knowledge broadly
Education: Bachelor of Arts (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: R209
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.