Job Title: Compliance Manager
Location: Case Main Campus
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 9532
Job Description POSITION OBJECTIVE

Working with a high degree of independence and under limited general direction, coordinate the major activities of the Center for Global Health & Diseases (CGHD) in international human subjects and related technical and logistical areas. It is imperative for the CGHD to comply with the complex regulatory requirements for international research, in order to facilitate the initiation and continuation of funded studies, and to meet all grant funding requirements. The Compliance Specialist/International Protocol Coordinator will take full responsibility for compiling and editing scientific and technical information within the Center and its various foreign collaborators in order to develop and update human subject protocols that are required for funded research projects, and the follow up necessary to process these through 4 separate and distinct levels: 1) the Center/Departmental Review, 2) the appropriate institute within NIH for DMID (Division of Molecular Biology and Infectious Diseases-NIAID) and sponsor/funding agency approval, 3) the Institutional Review Board at UHC/CWRU or the VA IRB, 4) the corresponding foreign Ethical Review Committees where the studies are taking place overseas. Take the lead in working with Center faculty, post docs, research associates, lab personnel and other scientific personnel in the development and continuing renewals of protocols, as well as in the scientific compliance of ongoing projects (good clinical practices workshops and other certifications, import permits, export permits and controls, shipping requirements, clearance of research supplies through customs, animal use approvals, FWAs, MTA’s and other required approvals and certifications, etc). Assist faculty and other research personnel with scientific and technical aspects of proposals, progress reports, manuscripts, database management, etc. Work with foreign investigators and scientists to accomplish the aforementioned tasks. Facilitate domestic and foreign correspondence as needed, stay abreast of new federal regulations in scientific compliance and disseminate this information to the Center and its collaborators, attend annual meetings. Some foreign travel may be necessary.

ESSENTIAL FUNCTIONS

Develop and draft human subject protocols, consent forms and all other pertinent IRB submission information. Use independent judgment to address issues when seeking information from investigators and other scientific personnel, in order to craft a final version to begin the 4 level approval process. (20%)Work with project sponsors such as NIH/NIAID/DMID (Division of Microbiology and Infectious Diseases) officers to refine and finalize the draft human subject protocols, consent forms and all other pertinent submission details in order to move forward with the remaining 3 levels of approval: a) Center/Departmental Review Committee, b) UHC or VA IRB institutional approval, and c) Foreign site Ethical Review Committee approvals (where the endemic populations are being utilized and studied). (15%)Administer pre award grant submissions. Assemble, review, edit, and/or correct all grant applications and post award progress reports requirements for faculty, research staff, and students based in the Neuropathology research track for accuracy and thoroughness prior to submission through the electronic signature process. Advise and direct faculty on budget development and justifications for proposal submissions. (10%)Upon DMID or other sponsor approval, submit protocols, consent forms, etc. to Center Review Committee before submission to UHC/CWRU or VA IRB office. Coordinate all activities of the Center Review Committee (departmental review committee) prior to submission of protocols to IRB. (5%)Submit IRB and IACUC protocols through required electronic submission systems (i.e. IRIS) and field questions and provide supplementary information as needed to IRB members for approvals. (5%)Implement and maintain a complex and detailed recordkeeping system to ensure that applications are processed and reviewed in time for regulatory requirements (e.g. NIH JIT), and for continuing review for awarded and other ongoing projects. (5%)Disseminate and/or post approvals and updates on the Center server for access to PIs, scientific personnel, and administrative personnel for grant proposals, awards, progress reports, JIT, and Foreign Ethical Review Committee queries. (5%)

NONESSENTIAL FUNCTIONS

Edit and provide input, guidance, and recommendations for language used in frequent grant proposal submissions related to human subjects and animal studies, to principal investigators and other scientific laboratory staff. (5%)Provide input, guidance, and recommendations for active projects, in addition to initial and yearly renewal approvals for ~25 funded active CWRU based research projects and domestic collaborators/subcontractors. (5%)Provide input, guidance, and recommendations for active projects to principal investigators and other scientific staff regarding human subject research in ~32 overseas active research sub projects (17 distinct collaborations in developing countries such as Brazil, Papua New Guinea, Solomon Islands, Kenya, Uganda, Madagascar, Ghana, Cote d’Ivoire), and 15 official subcontracts with Australia, UK, Germany and Switzerland. (5%)Assist international collaborators with developing their project specific protocols (incorporating our approved U.S. project specific protocols) for processing and approval by their respective foreign Ethical Review Committees. (5%)Apply for and maintain FWA (federal wide assurance) for international collaborating sites as needed to assure federal funding requirements. (5%)Overseas travel for conducting workshops for foreign investigators, scientists, lab and administrative personnel regarding human subject compliance and updated federal regulatory requirements, human subject certifications, conflict of interest, import etc. (%)Develop and implement domestic workshops for Center faculty, other investigators, lab personnel and other outside medical community audiences through the WHIG (World Health Interest Group Seminar weekly series) for human subject protocols, compliance, updated federal regulatory requirements, and human subject certifications, etc. (%)Coordinate individual human subject certifications for domestic and foreign PI’s, co-investigators and laboratory/ research staff; this involves facilitating the online course tutorials and certifications for foreign collaborators as well as campus based CITI and CREC certifications. (%)Maintain regulatory binders/documentation (electronic and/or hardcopy) for all studies according to federal regulatory requirements. Ascertain that these are also supplied to the foreign field sites for site monitor visits and other audits. (%)Work with investigators and international field staff to monitor human subject study activity, reporting and resolving adverse events, protocol deviation reporting and other regulatory compliance issues related to the projects. (%)Assist faculty and lab managers with compliance with laboratory safety and regulatory requirements including documentation with lab safety and operating procedures. (%)Develop and review study specific SOPS; able to provide consultation to local IRBs on policies and procedures related to international studies. (%)May co-author research projects or develop proposals independently for submission to NIH, Fogarty International Center, NGO’s or private foundations for human subjects regulatory projects. (<1%)Develop procedures to coordinate information with others as needed. (<1%)Perform other duties as assigned. (<1%)

CONTACTS

Department: Daily contact with investigators, lab personnel, administrative staff to discuss protocols, continuing renewals, progress reports, human subject and, animal research studies, MTA’s, FWA’s, new regulations, other compliance issues.

University: Frequent (weekly) contact with other departments and/or select audiences to share information and provide consultation and regulatory information, specifically in the area of international research. Occasional (monthly) contact with central offices such as OSPA and SOM OG&C to clarify new regulations, procedures and to inform and disseminate new information regarding international research study subjects compliance issues and requirements.

External: Regular (daily and weekly) contact with foreign collaborators as well as with the UHC/CWRU and VA IRB offices. Occasional (monthly) contact with sponsoring agencies such as NIH/DMID, Fogarty International Center, and their program officers and officials to clarify needs and refine draft protocols.

Students: Occasional contact with student trainees for protocol needs.

SUPERVISORY RESPONSIBILITY

May supervise temporary or student help.

REQUIREMENTS

Experience: 5 years of related experience with IRB and human subject regulatory requirements preferred.

Education/Licensing: Bachelor degree required. Master’s degree preferred.

Education/Licensing: Bachelor’s degree required. MA or MPH; a background or degree in science strongly preferred. Certification as CIP (Certified IRB Professional) required. Human Subjects Regulations certification. CCRC certification desirable.

ESSENTIAL SKILLS

Must have experience with IRB and IACUC functions and requirements, as well as experience with IRB and animal studies electronic submission systems. Experience in laboratory procedures strongly preferred. Knowledge and experience with NIH grants preferred.Knowledge of commonly-used concepts, practices, and procedures within the particular field of international research and human subject compliance. Cultural sensitivity and openness to diversity; ability to communicate tactfully and effectively in spite of language and cultural barriers.Proven writing and editorial skills, as well as laboratory skills or familiarity with lab procedures and scientific terminology, theories and content.Must be able to communicate effectively orally and in writing and interact proficiently with investigators, administrative staff, NIH officers, sponsors, medical doctors, scientists, lab personnel, field/research staff (domestically and abroad).Presentation skills.Able to work as a team member, taking the lead with investigators and lab personnel.Knowledge of NIH, FDA regulations, compliance issues, Good Clinical Practices (GCP), facilitate adherence to existing policy and procedures.Develop procedures in concert with the Center Review Committee and Center Administration to implement research regulatory requirements.Effective use of pre-established guidelines and background experience to perform the functions of the job. Self-starter and ability to work independently.Advanced knowledge and experience with computers, word processing, scientific graphics, desktop publishing. Knowledge of the IRIS system a plus.Strong organizational and time management skills essential.Knowledge and experience with IRB/IACUC electronic submission systems.Ability to meet consistent attendance.Ability to interact with colleagues, supervisors, and customers face to face.

WORKING CONDITIONS

Will work in an administrative office in addition to general laboratory environment. Must have the ability to work in a fast paced and complex environment with constant deadlines and juggling of priorities. Must be flexible to allow for occasional additional time when needed for deadlines. International travel may be necessary for educating collaborators and/or protocol completion.

Diversity Statement

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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Reasonable Accommodations

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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COVID Vaccination Case Western Reserve University has implemented a COVID Vaccination policy requiring evidence of COVID-19 vaccination for all students, faculty and staff with an on-campus presence. Religious and medical exemptions may be provided in accordance with applicable federal and state laws. For more information go to: https://case.edu/equity/covid-19-accommodations. Applicants may contact the Office of Equity at 216-368-3066 /equity@case.edu for information regarding religious or medical exemptions as an accommodation.