Research Regulatory Manager in Lexington, Kentucky at University of Kentucky

MA

6 yrs

None

Light lifting up to 25 lbs., long hours at computer station, high levels of concentration for most tasks.

Normal daytime shift

The Center for Clinical and Translational Science (CCTS) is seeking a highly motivated, professional Research Regulatory Manager to contribute to the variety of perspectives and excellence of our department and to assist the faculty and staff of our fast-paced research center. The CCTS helps campus research professionals meet their goals and improve health outcomes across Kentucky communities.

Our vision is to foster collaboration and innovation in healthcare, education, research, and community partnerships. We are committed to advancing translational research that improves public health, particularly in regions with limited access to care.

Since its inception in 2006, the CCTS has invested millions of dollars in research funding and trainee support at the University of Kentucky through its commitment to funding innovative, early stage translational research. In support of that vision, the Research Regulatory Manager role will serve as a team member of the Regulatory Knowledge and Support Core.

Responsibilities for this position include the ability to demonstrate subject matter expertise in HSP, RCR, HIPAA, and Good Clinical Practice (GCP) standards; expert knowledge of institutional, local, state and federal regulations as they relate to clinical research. Orchestrate applicable training for team members; assess and determine solutions for regulatory shortcomings of protocols, as appropriate. The employee will oversee RRS staff to ensure the IRB submission, maintenance and close-out process is completed accurately and in a timely fashion; may prepare UK IRB, Central IRB, FDA and other regulatory submissions for initial study start-up, annual reviews, and modifications required throughout study lifecycle and oversee regulatory unit recharge process to ensure that time and procedures are tracked and billed appropriately to grant accounts according to cost accounting standards.

Successful candidates will possess comprehensive understanding of related scientific, clinical and regulatory terminology. Ability to independently identify and problem-solve complex/non-routine problems. Strong organizational skills with attention to detail, strong oral/written communication skills, and strong interpersonal skills required. Demonstrate leadership, personnel management, task prioritization, and presentation skills. Computer and web-based application proficiency to include designing forms and spreadsheets using Microsoft Office applications. The CCTS is dedicated to broadening the range of perspectives within our staff and faculty and aims to build a team with an extensive spectrum of skills and experiences. The position will be hybrid-eligible (remote and in-person).

The CCTS encourages all qualified candidates to apply.

Comprehensive understanding of related scientific, clinical and regulatory terminology. Ability to independently identify and problem-solve complex/non-routine problems. Strong organizational skills with attention to detail, strong oral/written communication skills, and strong interpersonal skills required. Demonstrate leadership, personnel management, task prioritization, and presentation skills. Computer and web-based application proficiency to include designing forms and spreadsheets using Microsoft Office applications.

Master’s degree and at least 6 years of clinical or clinical research experience. Research certification (SOCRA, ACRP, etc.) preferred.

We value the well-being of each of our employees and are dedicated to creating a healthy place for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors, the University of Kentucky is a Tobacco & Drug Free campus.

The University follows both the federal and state Constitutions as well as all applicable federal and state laws on nondiscrimination. The University provides equal opportunities for qualified persons in all aspects of institutional operations and does not discriminate on the basis of race, color, national origin, ethnic origin, religion, creed, age, physical or mental disability, veteran status, uniformed service, political belief, sex, sexual orientation, gender identity, gender expression, pregnancy, marital status, genetic information or social or economic status.

Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.