Research Oversight & Compliance Officer (Hybrid)

Interested in joining a top team of scientists committed to providing the best medical care to pilots and astronauts? Do you have a passion for helping research maintain the highest level of legal and ethical standards? Ripple Effect is looking for a Research Oversight & Compliance Officer with eight years of experience to support our client's mission. This individual will work closely with Travis Air Force Base David Grant Medical Center/ Clinical Investigation Facility (CIF) to work with collaborators across the nation to support a growing Space Medicine research portfolio. Working with a team of scientists and clinical research nurses, the Research Oversight & Compliance Officer will oversee a biomedical research portfolio that focuses on improving the mission capabilities of the U.S. Air Force, Space Force, and NASA and is strongly aligned with Defense Health Agency and the Air Force Surgeon General's strategic initiatives. If this position sounds of interest, there's a place for you here at Ripple Effect! We are a diverse, progressive, and engaging work environment. We offer a multitude of incentives and flexible work options that work for you and your lifestyle. Responsibilities Animal Welfare Program Support: Review research applications and protocols to ensure consistency, completeness, and compliance with federal and state regulations, as well as institutional guidelines Prepare Institutional Animal Care and Use Committee (IACUC) agenda in preparation of committee meetings Attend IACUC meetings, document meeting minutes, and other related duties, as required Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions Monitor the regulatory environment and recommend changes as needed Attend seminars, workshops, and conferences in order to gain insight into new trends in animal research and to learn new approaches for the application of federal regulations Human Research Protections Program Support: Review applications in support of clinical investigations/research to ensure consistency, completeness, and compliance with federal and state regulations, as well as institutional guidelines Work with PIs to ensure that research applications communicate outcomes of research clearly Facilitate uploading all appropriate documents and files to the electronic IRB system (eIRB) Review Informed Consent Documents (ICDs) for protocol and amendment-specific content Perform initial and adjunct ethics and legal reviews of research applications for exempt and non-exempt review Support ongoing compliance and management of program audits of sponsored research programs Evaluate reports of unanticipated problems, protocol amendments and continuing review forms, and prepare recommendations to the IRB committee Coordinate a team approach to produce the monthly IRB agenda for each meeting and help ensure that materials are distributed within established guidelines Attend IRB meetings, record deliberations, document meeting minutes for IRB Chair approval Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions Assist with training and orientation tasks of new committee members Monitor the regulatory environment and recommend changes, as needed, to institutional officials Research Partnership and Intellectual Property Support: Draft, edit and track research collaborative agreements to include: CRADAs, Material Transfer Agreements, Non-Disclosure Agreements, MOUs, MOAs, Work Plans, Patent Licensing Agreement, Interagency Agreements, Invention Disclosures, etc. Support initial legal review of site-specific Cooperative Research and Development Agreements (CRADAs) and invention disclosures Review research plans and collaborative agreements for potential intellectual property rights and invention disclosures Ensure proper documentation and submission of appropriate disclosures to protect the rights of the Air Force and its collaborators Other duties, as assigned Minimum Education and Experience Masters' Degree in a related field Juris Doctor (JD) can substitute for MS/MA 8 years of animal welfare program, IRB, or human protections experience Basic Requirements Strong background in IACUC or IRB procedures and related research policies Experience advising, drafting, and coordinating collaborative agreements (CRADAs) Experience with invention disclosures, patents, patent law and related areas Highly organized, efficient, and extremely detail-oriented Demonstrated strength in verbal and written communication skills, including professional emails Must work effectively in a team environment Ability to prioritize among multiple projects in a fast-paced, deadline-driven environment, relying on your own resources and initiative Ability to work productively in Microsoft Office Suite, including Microsoft SharePoint to accomplish tasks Ability and willingness to travel to Fairfield, CA, to support key in-person meetings and audits Contract dictates that the following criteria must be met: Demonstration of current Basic Life Support certification (To be completed on own at least two business days prior to start date and must include an in-person skills assessment. AHA is the preferred certification vendor.) Demonstration of required immunizations, to include: COVID, HBV, Influenza, MMR, Tdap/Td, Varicella, Mantoux tuberculin skin test (TST)/QuantiFERON-TB Gold (QFT) (To be completed on own at least two business days prior to start date.) Successfully pass a Public Trust clearance as part of the onboarding process To be successful at Ripple Effect, you must be able to pay attention to details, clearly communicate, work independently, and have an eagerness to learn. Learn more about what it takes to become a Rippler here. Skills That Set You Apart Certificate in the Ethical Foundations of Animal Care and Use Certified IRB Professional (CIP) certification CITI training in accordance with local IRB policy Familiarity and/or experience with patent law or related areas Experience reviewing research collaborative agreements from a legal and regulatory perspective (e.g., CRADAs, Material Transfer Agreements, Non-Disclosure Agreements, MOUs, MOAs, Work Plans, Patent Licensing Agreement, Interagency Agreements, Invention Disclosures, etc.) If you don't have all of the skills above, don't be discouraged"”no resume paints a complete picture of a person. There's a good chance you're more wonderful than you think, so please apply!Before applying for this role, please read the following information about this opportunity found below.#J-18808-LjbffrRemote working/work at home options are available for this role.

Created: 2024-11-06