Associate Compliance Analyst, IRB

Title: Associate Compliance Analyst, IRB

Department Org: Office of Research Compliance - 107990

Employee Classification: U1 - Unclassified PSA FT

Bargaining Unit:Professional Staff Association

Primary

Location:

MC AC

Posted Salary:

Minimum $ 44,985.20

The Associate Compliance Analyst serves as a part of the leadership team in ensuring compliance with institutional, departmental, federal, and state regulations for the University’s oversight of human subject research activities.

The position will be responsible for protocol pre-review and analysis, and the review and disposition of materials related to the pre-reviews. This includes but is not limited to applications, informed consents for research, data collection tools, OHRP and FDA regulations and research related agreements, proposals and awards. The individual will provide direction and guidance concerning the requirements and obligations for the ethical and compliant conduct of human subjects research.

The position will require the individual to provide initial and ongoing educational and regulatory guidance and direction to investigators, research office staff, students, and Institutional Review Board (IRB) members.

The individual filling this position will be required to exercise independent discretion and decision‑making skills, yet also function as a departmental team member. Responsibilities include, but are not limited to, the appropriate handling of confidential and proprietary information, conflict of interest disclosures and the agreements/contracts related to federal and industry sponsored human subject research studies.

The individual may participate in interviews and training of research office staff. The individual will also provide backup support to management and provide directives to staff as appropriate. The individual will provide support as needed in other areas of research compliance such as responsible conduct of research and biosafety.

• Bachelor’s Degree.
• Two to three years professional level or research experience in human subject research, research processes, and regulatory compliance including but not limited to, the application of DHHS/OHRP, FDA and HIPAA regulations, informed consent process, knowledge of investigational drug and device regulations, interpretation and application of regulatory guidance and standards, knowledge of record keeping requirements meeting federal, state and local laws, the application of institutional policy, and compliance auditing.
  
  One (1) year of educational degree attainment above the minimum may be substituted for every one (1) year of experience.
• The individual must have a current knowledge and understanding of the federal regulations pertaining to human subjects research (i.e. DHHS regulations, 45 CFR 46, FDA regulations, 21 CFR 56, HIPAA Privacy and Security Rules).
• Must possess high-level organization skills, the ability to handle of multiple assignments and perform against deadlines with frequent interruptions and competing priorities.
• Demonstrated ability to work both independently and in a team-oriented environment.
• Demonstrated experience and precision in data gathering, compilation information, and preparation of reports.
• Experience in handling confidential information and materials including industry and sponsored research contracts.
• Must be willing to pursue additional education, attend regulatory conferences, and be able to attain C.I.P. certification through the Public Responsibility in Medicine & Research (PRIM&R) organization within three years.

• Skill in organizing resources and establishing priorities. Must be highly motivated, a self-starter, and very detail oriented.
• Must be able to maintain effective working relationships with personnel and professional staff
• Must be diplomatic and resourceful, highly organized with knowledge and skills of priority-setting strategies.
• Demonstrated excellent verbal, written, and culturally appropriate communication skills (including technical writing).
• Ability to analyze and solve problems and to make evaluative judgments:
  Critical thinking.
• Knowledge of current and emerging issues and trends in human research protections and compliance.
• Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures.
• Demonstrated computer literacy including proficiency in e-mail, electronic calendars, Internet, databases, and other office system software.…