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Sr Clinical Research Professional - Internal Auditor

Senior Clinical Research-Internal Auditor

UC Cancer Programs

University of Cincinnati, College of Medicine

 

The University of Cincinnati is a premier, public, urban research university; ranked as one of America’s top 26 public research universities by the National Science Foundation. U.S. News has ranked UC in the Top Tier of America’s Best Colleges. The Chronicle of Higher Education calls UC a “research heavyweight”. Forbes, Delta Sky and Travel + Leisure magazines have named UC one of the most beautiful campuses. #HottestCollegeInAmerica

 

UC is one of the largest employers in the Cincinnati region, employing over 15,000 full time and part time faculty, staff and student workers. The College of Medicine, Cancer Program is looking for a Clinical Research Project Manager. This position will support the University’s mission and commitment to excellence and diversity in our students, faculty, staff and all our activities. 

 

Job Duties and Responsibilities:

Performs the following audit and related QA activities for UC Cancer Institute human-subjects clinical trials under the direction of the UCCI Data & QA Manager:

 

  • Conducts routine and directed internal audits to ensure compliance with federal regulations (FDA, HIPAA), ICH-GCP, NCI requirements, the IRB approved protocol, institutional policies, UCCI internal SOPs; and, to ensure data quality and accuracy.
  • Prepares and distributes timely reports of audit findings to the research team and regulatory staff, reviews corrective action plans/audit responses for adequacy and assures corrective actions are taken by study teams through follow-up reviews and associated activities.
  • Assists with the development and maintenance of systems for tracking and reporting of compliance & QA metrics, assists with the preparation of reports to stakeholders as needed.
  • Identifies trends in audit findings and compliance metrics, and develops and implements educational programs, or corrective actions, for research groups to reduce instances of identified noncompliance.
  • Analyzes Investigator Initiated Trials (IIT) protocols to customize audit plans for protocol specific benchmarks in addition to assisting with the creation of case report forms, study specific SOPs/tools, and database form design (OnCore, RedCAP).
  • Serves as a trainer/mentor to UCCI research personnel, designing training & educational materials as needed and presenting such materials to groups of researchers & staff.
  • Assist the DSMB/PRMC Coordinator, Sub-site Monitor, and other UCCI research staff with auditing or QA activities as needed, including but not limited to: preparation for cooperative group audits, monitoring visits, and DSMB meetings.

 

Skills and Characteristics Needed:

  • Knowledge of, and ability to apply, IRB and federal regulations (FDA, OHRP, HIPAA) as they pertain to human subject research and the ability to interpret and apply laws, regulations and guidelines (ICH-GCP) to ensure the overall protection of human subjects.
  • Demonstrated ability to communicate sensitive matters diplomatically and tactfully with all levels of researchers, faculty, staff and external regulatory entities and industry sponsors.
  • Strong interpersonal skills, including the ability to build relationships and work collaboratively with all levels of researchers and staff to effectively educate, explain and provide advice relating to research compliance and best practices.
  • Exceptional written and verbal communication skills.
  • Strong administrative skills, including the ability to work independently, prioritize multiple projects, adhere to deadlines, maintain confidentiality and stay organized.
  • Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence.

 

Qualifications and Requirements:

  • Bachelor’s degree required, preferably in related discipline or equivalent education/experience.
  • Minimum 2 years of directly relevant experience in an academic or clinical setting.
  • Prior experience with human subjects auditing (FDA/GCP standards) is 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.

 

REQ: 30343 

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