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.
CSU Salary Schedule
*CSUMB provides pay scales representing its good faith estimate of what the university reasonably expects to pay for this position. The pay offered to a selected candidate will be determined on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, and CSU systemwide pay for comparable jobs.

Priority Screening Date: August 22, 2024
Recruitment Status: Extended

ABOUT CSUMB

California State University, Monterey Bay is a mid-sized university in California's Central Coast that grants undergraduate and graduate degrees. Powered by an inspiring Founding Vision Statement, CSUMB is part of the nation's largest four-year public university system, California State University, which educates nearly 460,000 students every year.

With a vibrant, diverse student body of over 7,000 students, CSU Monterey Bay is both a Minority Serving Institution and a Hispanic Serving Institution. Our staff and faculty transform students' lives with a focus on student success and engagement through experiential learning, service learning, and a strong emphasis on multicultural and global perspectives. CSUMB's sustainability goal is to be carbon neutral by 2030.

The university's Strategic Plan prioritizes inclusive excellence through recruiting and investing in developing a diverse body of faculty, staff and administrators. Many appreciate living and working close to the shores of beautiful Monterey Bay, with easy access to recreational areas from Big Sur to Santa Cruz. Nearby opportunities for collaborative research include working in the Monterey Bay National Marine Sanctuary and Silicon Valley, and with colleagues at local research universities, including UC Santa Cruz and Stanford University.

As one of the 23 campuses in the CSU system, CSUMB offers excellent benefits, including access to below-market-rate rental housing on East Campus, and competitive salaries for faculty and staff. With proximity to the San Francisco Bay Area and San Jose, opportunities for faculty, staff and students are as endless as the shores of the nearby Pacific Ocean.

PURPOSE:

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

KNOWLEDGE, SKILLS AND ABILITIES:

Thorough knowledge of and ability to apply extensive expertise to complex programs and/or administrative specialties, including pertinent laws and regulations. Demonstrated expertise in and advanced knowledge of the principles, problems, and methods of public and business administration and operational and fiscal management. Expertise in administrative survey techniques, operations and systems analysis, statistical and research methods, and the ability to interpret and evaluate results to develop sound conclusions and recommend new or revised policies.

Skills: Demonstrated expertise in and advanced knowledge of the principles, problems, and methods of public and business administration and operational and fiscal management. Expertise in administrative survey techniques, operations and systems analysis, statistical and research methods, and the ability to interpret and evaluate results to develop sound conclusions and recommend new or revised policies. Demonstrated consultative skills in working with internal and external constituent groups. Skill in the research, development and evaluation of policies and programs, including skill in the collection, evaluation, and interpretation of data to develop sound conclusions and make appropriate recommendations.

Ability to: take initiative and work independently to determine effective approaches to projects and priorities; organize, coordinate, and perform work in various situations where numerous and diverse demands are involved; apply extensive expertise to complex programs and/or administrative specialties, including pertinent laws and regulations; understand problems from a broad, interactive perspective and discern applicable underlying principles to conceive of and develop strategic solutions; work with representatives from public and private entities and handle potentially sensitive situations; effectively present ideas and concepts in written or presentation format and use consultative and facilitation skills to gain consensus; apply extensive expertise to the complexity of maintaining effective university-community partnerships in both face-to-face and online contexts; work with representatives from public and private entities and handle potentially sensitive situations.

MINIMUM QUALIFICATIONS:

Entry to this classification requires general knowledge and skills in the applicable administrative and/or program field with a foundational knowledge of public administration principles, practices, and methods. This foundation would normally be obtained through a bachelor's degree and/or equivalent training and administrative work experience involving study, analysis, and/or evaluation leading to the development or improvement of administrative policies, procedures, practices, or programs.

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.

SPECIAL CONDITIONS OF EMPLOYMENT & POSITION DESIGNATIONS:

• All offers of employment are contingent upon the successful completion of a background check (including a criminal records check).
• The person holding this position will have a duty to report to the Campus Title IX Officer information pertaining to discrimination, harassment, sexual misconduct, sexual exploitation, dating violence, domestic violence, stalking, and retaliation and is required to comply with the requirements set forth in CSU Executive Order EO 1095, EO 1096, and EO 1097 as a condition of employment.
• This position has been designated as a sensitive position with:
  • authority to commit financial resources of the university through contracts greater than $10,000
  • control over campus business processes, either through functional roles or system security access
• This position is designated as a Campus Security Authority (CSA). The position is required to participate in training at the direction of the Clery Director and must also promptly report allegations of reportable crimes according to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, its accompanying regulations; the California State Education Code, Chapter 15.5, of the Donahoe Higher Education Act, Section 67380; and the California State University system-wide policy, Code EO 1107.
• Must possess and maintain a valid license to drive in the State of California, pass the Defensive Training Class, and be insurable under the University's liability coverage.
• May require occasional evenings and/or weekend work.
• This position is eligible for hybrid or remote work assignment on an annual basis.

PHYSICAL ENVIRONMENT:

Office environment with standard equipment and tasks. The position requires working at a computer and desk for extended periods of time. Require travel between campus offices and off-campus locations.

The health and safety of our students, faculty, and staff remain our highest priority. While on campus, students, faculty, staff, and the community will be expected to follow all campus safety mandates.

BENEFITS/PERKS:

CSUMB offers a premium benefit package that includes outstanding vacation, health, dental and vision plans; membership in the California Public Employees Retirement System (CalPERS); and 15 paid holidays a year. For more information, visit Employee Benefits Summary. As a perk, the University Corporation at CSU Monterey Bay provides access to affordable campus housing based on availability; visit Schoonover Employee Housing for more information.

APPLICATION PROCEDURE:

For full consideration, applicants must complete the required online application prior to the priority screen date found at Careers at CSUMB. Application submissions received after the application screening date will be reviewed at the discretion of the University. Materials submitted become the property of CSUMB and will not be returned.

CSUMB is not a sponsoring agency for staff or management positions.

Reasonable accommodations will be provided for qualified applicants with disabilities who self-disclose by contacting Human Resources at (831) 582-3389 or emailing humanresources@csumb.edu. All employees must be eligible for employment in the U.S.

GENERAL INFORMATION:

CSUMB hires only individuals lawfully authorized to work in the United States and is an E-Verify employer. In compliance with federal crime awareness and campus security legislation, including the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics, you can view the notice of availability and access the Cal State University, Monterey Bay annual security and fire safety reports at https://csumb.edu/clery/asr-and-fsr-notices-availability/.

CSUMB is a smoke and tobacco-free campus.

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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