University of Cincinnati
Research Compliance Analyst or Specialist, Office of Research
University of Cincinnati, Cincinnati, Ohio, United States, 45208
Research Compliance Analyst Or Specialist, Office Of Research
Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 53,000 students, 12,000 faculty and staff, and over 350,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called "the most ambitious campus design program in the country." UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC's success. About The Office Of Research
The Human Research Protection Program (HRPP) protects the rights and welfare of research volunteers. Our team aims to enhance the research enterprise via education, community outreach, and streamlined processes while adhering to the highest standards and regulatory compliance. 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.
Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 53,000 students, 12,000 faculty and staff, and over 350,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called "the most ambitious campus design program in the country." UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC's success. About The Office Of Research
The Human Research Protection Program (HRPP) protects the rights and welfare of research volunteers. Our team aims to enhance the research enterprise via education, community outreach, and streamlined processes while adhering to the highest standards and regulatory compliance. 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.