Job Summary

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.

Job Duties

• 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.

Education

Bachelor's Degree- (Required)

Experience

Minimum of 4 years-Related work experience (Required)

Certification(s) and License(s)

Certified IRB Professional (CIP) - Default Issuing Body; Certified IRB Manager (CIM) within 2 years - Default Issuing Body

Skills

Organizing; Teamwork; Multitasking; Communication; Research Regulatory Environment

About Geisinger

Founded more than 100 years ago by Abigail Geisinger, the system now includes ten hospital campuses, a 550,000-member health plan, two research centers and the Geisinger Commonwealth School of Medicine. With nearly 24,000 employees and more than 1,700 employed physicians, Geisinger boosts its hometown economies in Pennsylvania by billions of dollars annually. Learn more at geisinger.org or connect with us on Facebook, Instagram, LinkedIn and Twitter.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.

Our Vision & Values

Everything we do is about making better health easier 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.

Our Benefits

We offer healthcare benefits for full time and part time positions from day one, including vision, dental and prescription coverage.