Establish and maintain processes and monitors practices to ensure regulatory documentation involving clinical trials that comply with Institutional Review Board (IRB) and governmental policies and procedures and regulations. Support the clinical research team (physicians, nurses, coordinators, etc.) in research efforts by facilitating the protocol approval process and by maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. Be responsible for the administration and regulatory compliance of clinical research within the department.
Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Maintain regulatory documentation.
Prepare and maintain FDA applications for INDs.
Serve as resource person or act as consultant within area of regulatory expertise.
Conduct internal audits.
Make and assist in modifying protocols and study documents.
Write reports, business correspondence, and procedure manuals.
Demonstrate a comprehensive understanding of contract principles, federal regulations, laws and UC/UCPC policy and operating procedures.
Work closely with UC and UC Health offices in negotiation of contracts, confidentiality agreements and amendments related to the conduct of research activities.
Work with necessary parties to identify compliance, legal, IP and business/financial risk. Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments.
Prepare, develop, review and negotiate industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures.
Effectively negotiate budgets to obtain funding sufficient to successfully execute research as applicable.
Assist in planning and implementing the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities; compile and analyze data.
Coordinate nursing and patient care and/or patient follow-up functions of the clinical study including planning and developing related activities.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Act as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities.
Perform quality checks on data entered by others.
Assist with creation of case report forms.
Database creation, testing, and basic maintenance.
Act as liaison between study personnel and data entry specialists.
Create data entry instructions and train data entry specialists.
Related other duties, as assigned.
Minimum Requirements: Bachelor's degree in related discipline or equivalent education/experience. For nursing-focused role, BSN in the area of clinical specialization, Master's degree preferred. 2-5 years of directly relevant experience, preferably in an academic or clinical setting. For nursing-focused role, three years nursing experience, and two years of experience in the area of clinical specialization.
Degrees, Licensure, and/or Certification: Appropriate certification preferred. For nursing-focused role, current/valid RN license to practice in the State of Ohio and CR certification preferred.
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.
SF:OMJ SF:RM SF:INS SF:INS
Internal Number: 38482-en_US
About University of Cincinnati
HISTORY IN BRIEF - The University of Cincinnati is a public urban serving research institution that was founded in 1819 and today is one of the country’s largest universities offering more than 350 academic programs to more than 44,000 students. UC has many top ranked programs in areas such as Music and Arts, Medical and Human-Services, Criminal Justice and more. Located in an urban setting, UC is close to the heart of Cincinnati and allows easy access for students to enjoy all that the city offers. UC is also the alma mater of many notables such as President William Howard Taft; Albert Sabin, developer of the oral polio vaccine; Astronaut Neil Armstrong and Mary Weinberg, 2008 Olympic gold medalist. UC is classified as a Research University (Very High Research Activity) by the Carnegie Commission and is ranked as one of America’s top 35 public research universities by the National Science Foundation. UC jumped 17 spots in the U.S. News & World Report rankings in the past two years alone. In addition to being named a “green university” by Princeton Review, UC has been named one of the world’s most beautiful campuses by Forbes and Delta Sky magazines. Learn more at www.uc.edu.MISSIO...N STATEMENT - The University of Cincinnati serves the people of Ohio, the nation, and the world as a premier, public, urban research university dedicated to undergraduate, graduate, and professional education, experience-based learning, and research. We are committed to excellence and diversity in our students, faculty, staff, and all of our activities. We provide an inclusive environment where innovation and freedom of intellectual inquiry flourish. Through scholarship, service, partnerships, and leadership, we create opportunity, develop educated and engaged citizens, enhance the economy and enrich our University, city, state and global community.