The IRB Reliance Analyst is responsible for having the knowledge and ability to conduct regulatory activities pertaining to the review of initial submissions, continuing reviews and amendments submitted to external IRBs. During the lifecycle of the study, responsible for ongoing reviews to assure the integrity of the submissions, study files, and federal grants, for coherence and agreement with regulations and institutional policies. The Reliance Analyst is the primary point of contact and source guidance for single IRB review and reliance/master agreements.
The IRB Reliance Analyst position requires strong knowledge in human subject research which is typically acquired through experience in the field and on-going study of regulations, guidance, and accreditation standards. The IRB Reliance Analyst functions with minimal supervision and demonstrates maturity of judgment, tact, and professional discretion given the nature of the IRB and IRB-related issues. A working knowledge of state and federal regulations is essential. Excellent organizational, interpersonal and communications skills, acute attention to detail, ability to prioritize multiple competing tasks and demands and professional writing skills are essential to success. The IRB Reliance Analyst must have excellent organizational and interpersonal skills and the ability to prioritize multiple, competing tasks and work under a deadline.
The IRB Reliance Analyst is expected to participate in and contribute to the review and revision of processes, practices and materials in order to continually advance performance improvement. These improvements will also require the member to function as a member of our team contributing to the accrual of information required for annual reporting, actively participate in site visit preparation and actively participate in regulatory audits for FDA, OHRP and AAHRPP accreditation of the Human Research Protection Program.
Acts as liaison between the external IRBs and researchers, serving as a primary point of contact and subject matter expert on the regulations that govern the conduct of research with human subjects. For studies that qualify for review by an external IRB, conducts independent, in-depth reviews focusing on institutional and regulatory compliance, assuring the protocol and informed consent are consistent with each other taking into consideration all modifications made to the study to date. Determine whether local institutional and other regulatory requirements have been met, such as completion of appropriate study team training, prior to sending the protocol to an external IRB. This responsibility also includes review of proposed consent forms to evaluate whether they contain institutionally required language and review of HIPAA documents to ensure their accuracy.
What you will do:
Reviews, negotiates terms and facilitates the execution of IRB reliance agreements.
Coordinates and oversees activities related to institutional responsibilities as outlined in the agreements and/or dictated by federal, state or local laws and policies.
Advise and provide consultative services to researchers and research staff to facilitate use of IRB authorization agreements.
Prepare, negotiate, coordinate and track IRB review and documentation pertinent to the use of IRB reliance/master agreements for situations when Baystate Health relies on an IRB at another institution.
In collaboration with the HRPP Director, develops policies, procedures, and tools to facilitate and streamline practices related to the reliance agreement review process, institutional responsibilities, and local review as applicable.
Responsible for providing clear and accurate instructions, guidance, and support to research investigators and staff throughout the entire regulatory process. This includes assistance in creating successful and regulatory compliant applications for IRB review utilizing the electronic submission system, submission requirements, federal and state regulations, guidance, standards, and IRB expectations and timelines. Provides relevant information and guidance on training and other requirements.
Responds to queries from principal investigators and staff in a professional and timely manner.
Actively participates in problem-solving and quality improvement activities with other members of the HRPP and IRB team.
Proactively identifies opportunities for improvement. This includes actively participates in the development of submission forms, reviewer worksheets, internal checklists, policies, and guidelines in order to allow the researchers and the institution to function with regulatory compliance.
Actively pursue activities to enhance their knowledge base and expertise in the interpretation and application of regulations, guidance, and standards.
Expected to keep up-to-date on new trends in human research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of increasingly sophisticated technology and increasingly complex ethical questions by attending conferences, meetings, and other educational opportunities in order to maintain and improve knowledge for advanced application of Federal and State regulations, guidance, and AAHRPP accreditation standards as necessary.
Responsible for informing and educating the IRB and HRPP staff of changes in the regulations or local review process around external IRB review.
Develops and generates in a timely manner FDA and OHRP compliant documentation, action letters, and other correspondence necessary in order to document the institution review process, guidance, and accreditation standards.
Assist with cross coverage of IRB Analyst colleagues when needed. This includes being responsible for tracking attendance, quorum, and votes in compliance with "common rule" laws along with facilitating the review process by serving as an intermediary between the IRB and the investigators by obtaining additional information and clarification as needed.
Assist with annual reporting, site visit preparation and regulatory audit preparation for FDA, OHRP and AAHRPP Accreditation of the Human Research Protection Program.
Tracks reviewer activities, specified events, and IRB timelines for internal and external reporting purposes; including but not limited to those required for current National Accreditation.
What you will need:
Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research.
Working knowledge of local and federal regulations for human subject’s research (ICH-GCP, OHRP, FDA regulations).
Minimum of 2 years of effective and relevant work experience in HRPP or IRB. Completes and maintains CIP or CIM certification with one year of eligibility.
CIP (Certified IRB Professional) or CIM (Certified IRB Manager). Preferred at entry, required within one year of eligibility.
Internal Number: BJ57
About Baystate Health
Baystate Health is a not-for-profit, integrated health care system serving over 800,000 people throughout western New England.
WHO WE ARE
With roots dating to the founding of Springfield City Hospital in 1873, Baystate Health has been providing high-quality and compassionate health care in the Pioneer Valley for more than 140 years.
Our facilities and services include:
• Baystate Medical Center: a teaching hospital, and the region’s only level 1 trauma center
• Baystate Children’s Hospital: the region’s only accredited, full-service children’s hospital
• Three community hospitals
• A network of more than 80 medical practices
• Health New England, a health insurance provider
• Home care and hospice services
Comprehensive regional laboratory and diagnostic services
OUR MISSION AND IMPACT
Our mission is to improve the health of the people in our communities every day, with quality and compassion. With a focus on quality, safety, value, and patient experience, Baystate is not only a keystone of our region – we are also a national leader in health care.
Baystate Health is the largest health care organization in western Massachusetts. The care we provide plays an ess...ential role in health of the people in our communities. Our impact is felt from the patient bedside to the classroom to the workplace and beyond.
As an integrated academic health system, the advancement of knowledge is a major component of our mission. Serving as the regional campus of the University of Massachusetts Medical School, we educate and train current and future caregivers – preparing much of our region’s health care workforce to meet patients’ needs for years to come.
Facts & Figures
With a workforce of nearly 12,000 team members, Baystate Health is one of western Massachusetts’ strongest economic engines. With more than 980 beds across our five hospitals, we are working to make health care accessible to people in our region.
Our annual impact includes:
• Over 1.8 million outpatient visits, providing comprehensive sick and preventive care
• Over 197,000 emergency and urgent care visits
• More than 36,600 surgeries performed
• More than 4,000 babies born at Baystate Health hospitals