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HealthPartners is currently hiring for a Senior Research Subjects Protection Coordinator. The coordinator is the main point of contact for investigators and research staff conducting research. The coordinator works independently and in a team environment and assists in the identification of potential regulatory issues with human research protocols and provides technical support and procedural guidance to investigators and research staff. This position requires substantial evaluation and problem solving. Challenges include working in a very fast-paced environment involving multiple ongoing studies; coordinating with personnel who are often under intense timelines and maintaining positive working relationships with investigators while pursuing responses necessary for the approval of research. Required Qualifications: Bachelor's degree or equivalent experience. 5 years of experience in a research and/or regulatory environment, preferably in the health care industry. Experience interpreting guidelines, policies, and federal and state regulations. Working knowledge of the following regulations: HIPAA Common Rule (Health and Human Services research regulations) FDA regulations and ICH guidelines USDA and OLAW regulations AAAHRPP elements and standards AAALAC elements and standards Excellent verbal and written communication skills Demonstrated people skills. Strong time management and organizational skills Ability to learn and utilize new software programs. Preferred Qualifications: Certified IRB Professional (CIP) preferred. Hours/Location: M-F; Days This position may work in a hybrid capacity and will be expected to work from our Bloomington corporate office upon request. Accountabilities: Pre-reviews and coordinates incoming research submissions for the Research Subjects Protection Program (RSPP) Office Provides program coordination for investigators, research staff and research reviewers by reviewing new application submissions and ensuring all required materials are submitted and fall within regulatory criteria and assurances. Manages the electronic application workflow from initial submission to approval while keeping open communication with colleagues (primary reviewers, IRB members and Committee Chairs, Investigators, and research coordinators). Creates IRB correspondence to research investigators and study teams regarding approval of initial study submissions, amendments, and continuing reviews. Maintains accurate records in compliance with Federal, State, and local regulations and institutional policy. Maintains the electronic human subjects record system and provides ongoing support to investigators, research staff, and other end-users. Creates reports as required and upon request using the electronic system. Committee Support Provides program support to the HealthPartners Institute Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC). Participates in the research subcommittee review process, including the HealthPartners Institute Administrative Review Committee and the Research Review Committee. Issues review assignments and instructions through the electronic database to IRB and IACUC members. Works with the Director, Research Integrity, to resolve questions and concerns that arise during the review process. Analyzes study applications to confirm completeness and compliance with appropriate federal regulations, guidelines, and institutional policies. Attends the IRB and IACUC meetings and records minutes of proceedings. Creates and sends out correspondence to investigators regarding the outcome of IRB and IACUC meetings. Post Approval Monitoring (IRB/ACUC) Oversees the IRB and IACUC reporting processes. This includes the continuing review of ongoing research, changes to approved research, and the reporting of unanticipated problems and protocol deviations. Composes clear, concise, and detailed correspondence to principal investigators to ensure that committee concerns are appropri tely addressed. Evaluates investigators' responses to concerns to determine if they are adequate or if additional information is needed. Provides program support to the Research Subjects Protection Program Maintains the RSPP's training and education program through CITI. Reviews training requirements on an ongoing basis and ensures all research personnel have completed appropriate training prior to beginning research. Provides clear communication and answers investigator and research staff questions regarding regulatory requirements and guidelines. Triages questions to the Director when needed. Reviews and updates institutional policies and procedures, as needed. Supports the Director during internal and external compliance audits and accreditation visits. Maintains a current understanding of Federal and State laws, regulations and guidelines governing human subject and animal research; attends educational and professional seminars as required to stay current in these areas. Acts as a liaison between the Research Subjects Protection Program, IRB and IACUC members, and research investigators and staff. Participates in on-going quality improvement activities. Performs other duties as assigned. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.