Research Integrity & Compliance Officer

at  California State University Monterey Bay

RESEARCH INTEGRITY & COMPLIANCE OFFICER

Job no: 541284
Work type: Staff
Location: Monterey Bay
Categories: Unit 9 - CSUEU - Technical Support Services, Administrative, Probationary, Full Time, Telecommute eligible (work onsite as scheduled and/or as requested and telecommute as scheduled)
Classification: Administrative Analyst/Specialist III
Hours: Full-time / 40 hours per week
FLSA: Exempt
Anticipated Hiring Salary Range: $7,540 to $8,167* mo.

KNOWLEDGE, SKILLS AND ABILITIES:

Knowledge: Working knowledge of the practices, procedures and activities of the Cooperative Learning Center or of learning center theory and research more broadly. General knowledge of the methods and problems of organizational and program management. General knowledge of research and interview techniques; and of the principles of individual and group behavior.
Skills: Proficient in the use of personal computers including word processing, spreadsheets and database software, and Google mail and calendaring programs.
Ability to: Ability to interpret and apply program rules and regulations; use initiative and resourcefulness in planning work assignments and in implementing long-range program improvement; obtain factual and interpretative information through interview; reason logically, collect, compile, analyze and evaluate data and make verbal or written presentations based on these data; advise students individually and in groups on routine matters where required; establish and maintain cooperative working relationships with faculty, CSUMB administrators, student organizations, private and public agencies and others in committee work, and student advising and community contacts; and, rapidly acquire a general knowledge of the overall operation, functions, and programs of the campus to which assigned.
Demonstrated ability to make decisions and carry through actions having implications with regard to other program or service areas. Ability to present clear and concise information orally and in written reports as part of the project evaluation processes. Ability to work independently, manage multiple projects and adhere to deadlines. Ability to contribute to a team effort to accomplish program goals and objectives.

MINIMUM QUALIFICATIONS:

Experience: Possession of this knowledge and ability is typically demonstrated through the equivalent of two years of professional experience in one of the student services program areas or in a related field; experience should give evidence of competence and indicate the potential for further growth. A master’s degree in a job-related field may be substituted for one year of professional experience.
Education: Equivalent to graduation from a four-year college or university in one of the behavioral sciences, public or business administration or a job- related field. Additional specialized experience during which the applicant has acquired and successfully applied the knowledge and abilities shown above may be substituted for the required education on a year-for-year basis.

PREFERRED QUALIFICATIONS/DESIRABLE EXPERIENCE:

• Master’s degree or higher in a relevant field (e.g., science, ethics, regulatory affairs).
• Previous experience in research compliance, preferably in an academic or research institution setting.
• Demonstrated ability to develop and maintain in-depth knowledge of federal regulations governing research (e.g., human subjects protection, animal welfare, biosafety).
• Experience with IRB and/or IACUC processes, including protocol review and compliance monitoring. Strong knowledge of ethical considerations and protections for vulnerable and specific subject populations, both human and animal.
• Experience with eRA systems/platforms, such as Cayuse, to manage data and information.
• Strong understanding of funding agency regulations and compliance requirements.
• Extensive knowledge of research data management and retention, conflict of interest issues, and responsible conduct of research.
• Familiarity with software tools and platforms used for management and storage of data, as well as research administration.
• Excellent communication skills and ability to collaborate effectively with diverse stakeholders.
• Attention to detail, critical thinking skills, and ability to make informed decisions in complex regulatory environments.
• Certification in research administration (e.g., Certified IRB Professional, Certified Research Administrator) preferred.

EQUAL OPPORTUNITY EMPLOYER:

CSUMB is an Equal Opportunity employer seeking to recruit and support a broadly diverse community of faculty and staff. We value and celebrate diversity in all its forms and strive to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion. We consider qualified applicants for employment for their anticipated contributions and without regard to race, color, religion, national origin, age, gender, gender identity or expression, sexual orientation, genetic information, medical condition, pregnancy, marital status, veteran status, or disability.
To apply, visit https://careers.csumb.edu/en-us/job/541284/research-integrity-compliance-officer
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Under the supervision of the Associate Provost for Research, the Research Integrity and Compliance Officer will play a pivotal role in upholding research integrity standards, managing compliance programs, and supporting faculty, staff, and students engaged in research endeavors. This position is responsible for ensuring that both ethical and legal requirements are known and observed in the conduct of all research and sponsored program activity. In addition, this position is responsible for keeping campus and partner stakeholders informed of changes to research ethics, regulations, laws, and policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following:

• Institutional Review Board (IRB): Facilitate the IRB review process, ensuring that all human subjects research protocols comply with federal regulations (e.g., 45 CFR 46) and university policies. Provide guidance to researchers on protocol submission, modifications, and renewals. Author correspondence that conveys IRB deliberations and decisions. Maintain IRB records and filing processes. Initiate and coordinate writing and revision of forms and procedures, procedures manuals, campus policy, and training processes. Engage IRB members and stakeholders in quality improvement processes. Identify, manage, and report on adverse events.
• Training and Education: Provide training and technical assistance for the members of campus compliance committees (e.g., IRB, IACUC, and Biosafety). Develop and deliver training programs on research integrity, compliance requirements, and ethical conduct for researchers, staff, and students. Promote awareness of ethical issues and best practices in research. Construct and maintain the research compliance website. Foster a culture of compliance and ethical research practices across the university. Communicate and collaborate with other CSU Research staff to share best practice information.
• Responsible Conduct of Research (RCR): Ensure compliance with federal RCR and RCER requirements, including those set by the NIH, NSF, USDA and others. Develop and update institutional policies and procedures related to RCR compliance. Develop and manage the process of collecting, reviewing and assessing RCR plans and training for researchers. Track and monitor participation in RCR training and maintain records of completion. Ensure RCR training meets the requirements of federal funding agencies. Provide education and resources on ethical research practices.
• Financial Conflict of Interest (FCOI) Compliance: Ensure compliance with federal regulations related to FCOI, including those from NSF, NIH and DOE. Manage compliance with California state requirements for 700-U financial conflict of interest disclosures. Develop and update institutional policies and procedures related to FCOI compliance. Review and assess FCOI disclosures submitted by faculty, staff and researchers to identify potential conflicts. Work with the FCOI Committee to develop and oversee management plans for identified conflicts. Ensure timely and accurate reporting of FCOI to federal agencies and maintain comprehensive records. Serve as the subject matter expert on FCOI compliance related to external funding.
• Funding Regulations: Interpret and apply regulations from funding agencies (e.g., NIH, NSF, DOE) related to research compliance, including financial disclosures, conflict of interest policies, and relevant procedures and policies related to proposal and award administration. Monitor changes in federal regulations and ensure timely updates in institutional policies, procedures, disclosures and training programs.
• Monitoring and Auditing: Conduct regular audits and review of research protocols, disclosures and training completions. Identify and address compliance issues and recommend corrective actions. Prepare and submit required compliance reports to regulatory agencies.
• Institutional Animal Care and Use Committee (IACUC) and Biosafety (Institutional Biosafety: Committee; IBC) - 5%: Oversee the IACUC process for animal research protocols, ensuring compliance with federal regulations (e.g., Animal Welfare Act) and university standards. Collaborate with researchers to maintain ethical standards in animal research. Manage the biosafety program, ensuring compliance with federal regulations (e.g., NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules) and university biosafety policies. Provide guidance on risk assessment, containment measures, and safe practices in research involving biohazards. Author correspondence that conveys IACUC and IBC deliberations and decisions. Maintain records and filing processes. Initiate and coordinate writing and revision of forms and procedures, procedures manuals, campus policy, and training processes. Identify, manage, and report on adverse events.
• Federal Regulations: Stay abreast of federal regulations (e.g., Code of Federal Regulations Title 45, 21, and 42), guidelines, and policies related to research integrity and compliance.

Other Functions:

• Perform other job-related duties and special projects as assigned.
• Availability to work occasional evening and weekend hours as required.