"Research Compliance Analyst or Specialist, Office of Research"

Job Overview

The HRPP department is seeking a Research Compliance Analyst to join their team. The successful candidate may be appointed to a Research Compliance Specialist based on qualifications, experience, and skills. This position will need someone who has experience with human subjects, Institutional Review Board (IRB), and knowledge of regulations and guidelines pertaining to human research (ICH, GCP, and HIPAA). They will need to possess the ability to work independently, prioritize, interpret both internal and external research regulatory documentation, and have computer skills with knowledge of word processing, spreadsheets, databases, and graphics.

Essential Functions

Research Compliance Analyst

• Serve as liaison for designated research protocols/studies; perform initial/ongoing research protocol reviews and provide advice to the Board/Committee; perform protocol audits as required; attend Board/Committee meetings to review and discuss studies to ensure compliance with federal, state, local regulations, and University policies & procedures; act as a resource for Board/Committee members regarding regulations during research protocol review. Resolve all issues involving research protocols.
• Interpret, analyze and apply federal, state and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or known instances of noncompliance with university or federal regulations.
• Coordinate information to meet protocol-reporting requirements; resolve routine and non-routine issues involving research protocols including direct communication with investigators and research staff; interact with investigators, faculty, students and administration of all levels.
• Assist in the development and maintenance of daily operational policy and procedures.
• Perform related duties based on departmental need. This job description can be changed at any time.

Research Compliance Specialist

• Serve as liaison for designated research protocols/studies; perform initial/ongoing research protocol reviews and provide advice to the Board/Committee; perform protocol audits as required; attend Board/Committee meetings to review and discuss studies to ensure compliance with federal, state, local regulations, and University policies & procedures; act as a resource for Board/Committee members regarding regulations during research protocol review. Resolve all issues involving research protocols.
• Interpret, analyze and apply federal, state and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or known instances of noncompliance with university or federal regulations.
• Coordinate information to meet protocol-reporting requirements; resolve routine and non-routine issues involving research protocols including direct communication with investigators and research staff; interact with investigators, faculty, students and administration of all levels.
• Assist in the development and maintenance of daily operational policy and procedures.
• Provide training and mentoring as needed, may conduct on-site audits; may serve as full member on review board/committee.
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

Research Compliance Analyst

• Bachelor’s Degree in a related field. Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Research Compliance Specialist

• Bachelor’s Degree in a related field. Six (6) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

Research Compliance Analyst

• One (1) year of experience in a compliance, basic science or clinical research environment.

Research Compliance Specialist

• Two (2) years of experience in a compliance, basic science, and/or clinical research environment.

Additional Qualifications Considered

Research Compliance Specialist

• Relevant professional certification or an advanced degree.

Physical Requirements/Work Environment

Office environment/no specific unusual physical or environmental demands.

Application Process Information

A resume and cover letter are required as part of the application process. Attach these documents before submitting your application.

Compensation and Benefits

UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. Highlights include: Comprehensive Tuition Remission, Robust Retirement Plans, Real Work-Life Balance, and Additional Benefits like competitive salary, comprehensive health coverage, flexible spending accounts, wellness programs, and professional development opportunities.