Responsible for independently managing central administrative duties associated with the confidential review and approval process for human subject research protocols. Coordinates complex and broad administrative matters and independently provides comprehensive consultation, facilitation, decision support and educational programming to research faculty and staff. Identifies regulatory issues with human research protocols and provides procedural guidance for regulatory and compliance issues. Provides technical support for Institutional Review Board system users and serve as a liaison between the Institutional Review Board and investigators and study teams. Serves on Institutional Review Board. Committee as a designated reviewer and voting member.
Conducts a comprehensive pre-review of initial reviews, amendments, continuing reviews, and all related documentation prior to distribution for IRB member review or full committee review.
Analyzes protocols and study records to ensure completeness and compliance with appropriate regulations, IRB policies and guidelines as well as institutional polices.
Serves as an IRB Member and completes in-depth reviews of assigned submissions to assess IRB approval criteria and determine review outcome.
Independently conducts initial review of human research protocol applications, reviewing amendments, continuing reviews, determining the level of risk and appropriate review process to ensure compliance with regulatory requirements, institutional and Institutional Review Board policies and guidelines.
Advises investigators, study teams and IRB members about and ensures that institutional requirements for human subject research, and ancillary reviews such as Security, Privacy and Compliance, Institutional Biosafety Committee and Radiation Safety Committee reviews are completed and relevant information provided to reviewing IRB.
Identifies the need for policy deviations, clarifies special conditions and assists with developing solutions and finding compliant pathways when traditional research methods and strategies cannot be implemented
Interprets and provides comprehensive guidance to principal investigators, research staff, and IRB members on complex regulations impacting conduct and approval of human subject research.
Administers educational programs pertaining to human research protections and IRB review processes for IRB members, investigators, research and support staff.
Reviews, recommends, and revises applicable IRB Office Polices, standard operating procedures, guidance, checklists, forms and other documents to ensure compliance with applicable ethical principles, standards, regulations, guidelines, and policies.
Recommends process improvements to investigators and research staff.
Coordinates and attends convened Institutional Review Board meetings and independently prepares meeting agendas and materials, as well as IRB meeting minutes.
Records convened Institutional Review Board discussion and stipulations, and ensures accurate documentation of final IRB determinations are conveyed to the principal investigator and research team.
Responsible for independently composing clear, concise and detailed outcome letters to principal investigators and research team to ensure that committee concerns, questions and rationale are accurately and appropriately communicated to researchers.
Evaluates investigator's responses to determine if they are adequate or if additional information is needed.
Creates and supports an environment of collaboration and mutual support between IRB office staff and IRB Committee Members.
Demonstrates advanced comprehension of and ability to apply federal, state, and local laws, as well as organizational Institutional polices that govern human subject research when reviewing research protocols (e.g., Health and Human Services Common Rule, Food and Drug Administration, Good Clinical Practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, as well as federal and state laws governing informed consent, and substance use disorder, mental health and HIV AIDS records.
Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.
Bachelor's Degree- (Required)
Minimum of 4 years-Related work experience (Required)
Certification(s) and License(s)
Certified IRB Professional (CIP) within 2 years - Default Issuing Body; Certified IRB Manager (CIM) within 2 years - Default Issuing Body
OUR PURPOSE & VALUES: Everything we do is about caring for our patients, our members, our students, our Geisinger family and our communities. KINDNESS: We strive to treat everyone as we would hope to be treated ourselves. EXCELLENCE: We treasure colleagues who humbly strive for excellence. LEARNING: We share our knowledge with the best and brightest to better prepare the caregivers for tomorrow. INNOVATION: We constantly seek new and better ways to care for our patients, our members, our community, and the nation. SAFETY: We provide a safe environment for our patients and members and the Geisinger family We offer healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners. Perhaps just as important, from senior management on down, we encourage an atmosphere of collaboration, cooperation and collegiality. We know that a diverse workforce with unique experiences and backgrounds makes our team stronger. Our patients, members and community come from a wide variety of backgrounds, and it takes a diverse workforce to make better health easier for all. We are proud to be an affirmative action, equal opportunity employer and all qualified applicants will receive consideration for employment regardless to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
We are an Affirmative Action, Equal Opportunity Employer Women and Minorities are Encouraged to Apply. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.
At Geisinger, our innovative ideas are inspired by the communities we serve – like our Fresh FoodFarmacy, a program that delivers life-saving healthy alternatives to patients with diabetes. With additional tools like our MyCode Community Health Initiative, one of the first health system genome sequencingprograms, and our new asthma app suite that we developed in partnership with AstraZeneca, it’s no wonder we’re ranked one of the Top 5 Most Innovative Healthcare Systems by Becker's Hospital Review. We continually work towards continuous improvement in a culture where everyone has a voice and firmly believe that better begins with all of us.Founded more than 100 years ago, Geisinger serves more than three million residents throughout central, south-central and northeastern Pennsylvania and southern New Jersey. Our physician-led system is comprised of 30,000 employees, including 1,600 employed physicians, and consists of 1...3 hospital campuses, the Geisinger Health Plan, Geisinger Commonwealth School of Medicine and two research centers. What you do at Geisinger shapes the future of health and improves lives – for our patients, communities, and you.