Clinical Research Coordinator IIUniversity of Kentucky

BS

3 yrs

None

Sitting and or standing at workstation for extended periods, lifting/or carrying light weight objects. Potential to work with aggressive/combative individuals.

Mostly Monday – Friday days, other shifts as needed

The Division of Maternal–Fetal Medicine seeks a highly skilled clinical research professional responsible for supporting, coordinating, and executing complex perinatal research activities across the full clinical research lifecycle. This role requires advanced knowledge of scientific concepts and research design, ethical and participant-safety considerations, investigational product development, clinical study operations, data management, regulatory compliance, and cross-disciplinary collaboration.

The incumbent independently applies Good Clinical Practice (GCP), Human Subjects Protection (HSP), Responsible Conduct of Research (RCR), and all university, state, and federal regulations to ensure rigorous, ethical, and compliant research conduct. Core responsibilities include assisting investigators with protocol development; interpreting and operationalizing research protocols; coordinating study visits and workflow; identifying and reporting adverse events; supporting investigational product management; conducting informed consent processes; screening, enrolling, and monitoring study participants; and maintaining complete, accurate, and audit-ready regulatory and study documentation.

The role also provides skilled oversight of data collection and quality assurance processes, including development of source documents and data capture tools, timely and accurate entry into electronic data capture systems, query resolution, and collaboration with sponsors and CROs to ensure high-quality data and protocol compliance. The position supports internal audits, quality improvement activities, and adherence to institutional and federal reporting requirements.

In addition to operational responsibilities, the position contributes to literature searches, manuscript development, and continuous professional development. The incumbent mentors junior staff; coordinates with investigators, regulatory offices, sponsors, and clinical teams; and helps maintain effective workflows and communication across multidisciplinary research environments. Strong leadership, organizational skills, problemsolving abilities, and the capacity to manage complex studies with minimal supervision are essential to success in this role.

Strong attention to detail and excellent organizational skills. Proficient in operating various office machines including computers, printers, and various software packages. Robust interpersonal skills. Advanced knowledge of Microsoft Office products. Strong written and verbal communication skills. Initiative, collaboration, advanced time management skills. Technical skills applicable to essential functions and initiative.

Bachelor’s degree and at least 3 years of related experience. Clinical research certification (CCRC, CCRA, CCRP, 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.