Position Objective

Working under limited supervision, the Associate Director, Research Compliance provides leadership, coordination and technical expertise for university research compliance programs and committees, which includes the Case Western Reserve University Human Research Protection Program (HRPP) and the university Institutional Review Board (IRB). Additionally, this position provides support for the university IRB. The associate director will be responsible for the oversight, administration, and coordination of policies and procedures to ensure compliance with all federal, state, and local regulations and applicable institutional requirements. The associate director will lead and assist faculty members, staff, and students with the foundation and submission of research protocol applications. The associate director is a pivotal member of the Case Western Reserve University Office of Research Compliance.

ESSENTIAL FUNCTIONS

1. Review IRB protocol submissions (new, amendments, continuing reviews, protocol deviations, serious adverse events, and terminations) and communicate with the Principal Investigators, study teams, and committee members in the review processes. Uphold cross training and the knowledge to step in and review Institutional Review Board (IBC), Human Stem Cell Research Oversight (HSCRO), and Dual Use Research of Concern (DURC) protocol submissions, when needed. Responsible for the review of regulated recombinant DNA (rDNA) and synthetic nucleic acid work in cells, animals and humans conducted at Case Western Reserve University, University Hospitals Cleveland Medical Center, the Louis Stokes Cleveland Veterans Administration Medical Center and MetroHealth Medical Center. Work with other institutions for collaborative research projects and establish working relationships with each institution’s IRB office to coordinate Reliance Review Agreements and establish a single IRB of record. (70%)
2. Active involvement in the Quality Improvement Program review processes related to the IRB. Oversee the process to meet national accreditation standards under the direction of the executive director for research compliance. Serve as a key member of the accreditation preparation work group. (10%)
3. Generate and maintain a high volume of detailed policies and procedures to keep the IRB in compliance with the federal governing bodies and national accrediting board, state laws, and local policies as applicable. Continually stay up to date with the changing regulations and policies. Generate detailed policies and procedures for the university Human Research Protection Program (HRPP) and the IRB to meet deadlines and maintain the university’s HRPP “Full Accreditation” status. Develop, manage, and coordinate all policies and procedures, user and operation manuals, and workflow. Participate at the national level in professional organizations to help shape the future regulatory environment in the areas of ethical research. Participate in campus- city- and state-wide committees and workgroups representing ethical compliance. (10%)

NONESSENTIAL FUNCTIONS

1. Establish and implement long-range and short-term organizational goals, objectives, and operating procedures. Evaluate operational effectiveness and initiate improvements. Establish, evaluate, and oversee the administrative operations, policies, and procedures of the university IRB. Review, research and interpret changes, trends and new developments in the federal regulatory and compliance area pertaining to human subject protection and other ethical protection areas. Develop strategies to enable the university to successfully adapt to changes. Regularly communicate and disseminate appropriate information. Serve as expert consultant and liaison for university research compliance. Administer and help manage the daily business processes and functions of the IRB. This includes communicating with committee members by orienting them to the IRB and providing continuous support for each of them. Directly communicate with researchers to assist in the structure of their research protocol and where if falls within the regulations and/or policies of the designated committee. Manage the resolution of problems and issues. Work closely with the IRB committee chair, and university staff, researchers, university office of Sponsored Projects Administration, office of General Counsel, other offices and committees with responsibility for research compliance. Support the IRB advisory committee during their quarterly meetings by helping to generate harmonization between Case Western Reserve University and its four affiliated Cleveland area hospital IRBs Human Research Protection Programs (HRPP) and IRB processes. (5%)
2. Provide guidance, education, and training regarding protection of human subject research and the related operations. Ensure that all researchers who utilize the university IRB meet a standard of knowledge acceptable to regulators and the public at large with respect to ethical and human subject protections and the scientific and ethical framework of research. (5%)
3. Perform other duties as assigned. (<1%)

CONTACTS

Department: Daily with executive director for research compliance, associate directors for research compliance, associate vice president for research, executive director of research integrity, education and community outreach, director of conflict of interests. Daily contact with team members across the department to coordinate and promote research projects.

University: Daily with university faculty, staff, and students, various school research administration departments, and direct contact with the chairpersons and members of the various committees the research compliance manager will support.

External: Direct contact with affiliated hospital IRB offices, non-affiliated hospital and university IRB offices, and grants and contracts offices related to collaborative research activities. Direct contact with faculty and medical staff involved in research at affiliated and non-affiliated institutions collaborating with the university. Frequent contact with regulatory, accreditation, and professional societies related to research compliance.

Students: Direct contact with undergraduate, graduate, and professional students and post-doctoral fellows and scholars to help them in their research endeavors.

SUPERVISORY RESPONSIBILITY

No supervisory responsibility.

QUALIFICATIONS

Experience: 5 years of experience, preferably in an academic research campus and/or biomedical enterprise. Working in an IRB office or knowledgeable in the IRB process preferable. Experience teaching or training a plus.

Education: Bachelor’s degree required; Master’s degree or the equivalent preferred.

REQUIRED SKILLS

1. Technical and administrative leadership skills to analyze, evaluate, and communicate matters relating to areas of research compliance.
2. In depth knowledge of federal, state, city and other regulations governing research compliance.
3. In depth knowledge and understanding of the Common Rule and the Association for the Accreditation of Human Research Protection Program (AAHRPP) Elements.
4. Ability to maintain confidentiality and communicates tactfully regarding sensitive information.
5. Ability to meet consistent attendance.
6. Ability to work independently and able to balance a variety of tasks.
7. Solid critical thinking skill with excellent attention to detail.
8. Ability to prioritize workload to meet deadlines.
9. Excellent communication, writing, and interpersonal skills with the demonstrated ability to achieve common goals. Communicate effectively, orally and in writing. Ability to interact with colleagues, supervisors, and customers face to face.
10. Ability to create a supportive, advocacy-oriented environment.
11. Service-oriented skills, ability to use collaborative approach to customers and peer relationships.
12. High degree of maturity, independent judgment, and critical thinking.
13. Sophisticated understanding of academic and medical organizational cultures across institutions.
14. Ability to excel in a team environment.
15. Advanced competence utilizing MS Office suite, computerized databases.

WORKING CONDITIONS

Typical office environment. There may be large workloads, deadlines, frequent disruptions, and changes in priorities.

In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity.  Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.

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Case Western Reserve University provides reasonable accommodations to applicants with disabilities.  Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Equity at 216-368-3066 to request a reasonable accommodation.  Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.

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