Position Summary:
Serve as a research nurse on multiple clinical research studies for various sponsors including government agencies, cooperative groups, pharmaceutical companies, biotechnology companies, and/or medical device companies. Must follow the study protocol as designed and written by the study sponsor adhering to Good Clinical Practice as defined by the U.S. Food and Drug Administration, as well as other appropriate Regulatory agencies. May perform study related procedures for which trained and under the direction of the Principal or Sub-Investigator physician.
Essential Functions
Coordinates assigned clinical research studies from start-up to close-out, including care coordination, data collection, safety reporting, and completion of FDA and protocol required documentation, ensuring compliance with all applicable standards.
Serves as a liaison between investigators, study teams, sponsors, CROs.
Collaborates with other hospital departments and healthcare offices to conduct the study protocol.
Maintains effective, professional communication with physicians, patients, family members, research team, hospital departments, healthcare offices, and other stakeholders.
Performs subject screening, informed consent, and study procedures per the clinical trial protocol, in line with scope of practice and delegation of authority.
Maintains expert knowledge of assigned study protocols, departmental SOPs, departmental standard work, and regulatory guidelines.
Supports onboarding and training of new research personnel and serves as a back-up for team members as needed.
Maintains regular and reliable attendance.
Performs other duties as assigned.
Position Qualification:
Licenses and Certifications
RN - Registered Nurse - State Licensure and/or Compact State Licensure required.
BCLS - Basic Life Support current or obtained upon employment.
CCRP - Certified Clinical Research Professional or obtained within 2 years of employment preferred.
Qualifications
3+ years of clinical experience required.
Clinical research experience preferred.
Knowledge, Skills and Abilities
Strong written and verbal communication abilities.
Highly organized with excellent problem-solving and communication capabilities.
Capable of independently managing complex clinical trials.
Skilled in using Microsoft Office applications and Cerner EMR systems.
Demonstrates a commitment to ongoing process improvement.
Knowledge of applicable federal, state, local, and institutional regulations governing clinical research involving human subjects.
Able to analyze detailed information and make timely, informed decisions.
Works effectively in high-pressure environments with tight deadlines, frequent interruptions, and heavy workloads.
Possesses strong critical thinking skills and sound decision-making abilities.
Self-motivated with the ability to work independently as well as collaboratively within a team.
Thorough understanding of federal regulations and Good Clinical Practice (GCP) guidelines.
Located in Knoxville, Tennessee, The University of Tennessee Medical Center, has a rich history in the East Tennessee community of providing patient-centered care and remaining at the forefront of research, technology and treatments. UT Medical Center attributes its well-respected standing within the community to the exceptional people that dedicate themselves to patient care excellence. The hospital serves as a referral center for Eastern Tennessee, Southeastern Kentucky and Western North Carolina. It is the region’s academic medical center, Magnet® recognized hospital and Level I Trauma Center.