Research Study Coordinator 1

1w1 week ago

University of Tennessee

Knoxville, US · Full-time · $45,000 – $50,000

About this role

Under the direction of the GSM Director of Research, the Research Study Coordinator 1 coordinates Investigator-Initiated Research. This role assists faculty with clinical research activities, including development, submission, and management of regulatory paperwork. It handles IRB applications, annual renewals, and maintenance of study files and essential trial documents.

Daily tasks include assisting investigators with study design by reviewing proposals for best-suited methods. Coordinates initial IRB submissions, collecting agreements, personnel documents, and uploading into iMedRIS. Prepares study-specific protocols, source documents, logs, and files for execution.

The role supports screening potential subjects, documenting medical histories, obtaining informed consent, and coordinating study visits. Performs assessments like lab draws, questionnaires, and vital signs as needed. Maintains contact with study participants, families, community agencies, and health care providers.

Manages study-specific Master Trial File and Essential Trial Documents. Assists with IRB Continuing Reviews and study status reports. Coordinates Quality Assurance and Monitoring pathway audits with investigators and the Director of Research.

Requirements

Bachelor’s Degree in relevant health field (TRANSCRIPT REQUIRED)
One (1) year of relevant experience; OR Associate’s Degree and three (3) years of relevant experience, OR equivalent combination to equal five (5) years
LPN or medical background preferred
Ability to create and maintain extensive medical records on clinical research subjects
Understanding of hospital policies and procedures, medical records and documentation, and HIPAA regulations
Knowledge of research protocol with understanding of Basic Research Principles and Federal Code of Regulations for Clinical Research Studies
Ability to manage multiple priorities
Intermediate-level computer skills with ability to learn new software applications for electronic data capture programs

Responsibilities

Assist investigators with development of study designs by reviewing proposals to determine best-suited methods for study objectives
Assist with collection and submission process for initial Institutional Review Board (IRB) submissions including hospital collaboration agreements, key personnel documents, and IRB application completion
Assist investigator with IRB Continuing Review process including completion of study status reports
Prepare study-specific protocols, source documents/spreadsheets, required study logs, and essential trial documents
Assist in screening potential subjects, reviewing and documenting patient medical histories, obtaining informed consent, and coordinating study visits
Establish and maintain contact with study participants, families, community agencies, and health care providers
Assist with management and maintenance of study specific Master Trial File and Essential Trial Documents
Assist investigators and Director of Research with coordination of Quality Assurance and Monitoring pathway audits