Research Study Coordinator-Research Center (Knoxville)

University of Tennessee•Knoxville, TN

2d•Onsite

About The Position

Under the direction of the GSM Director of Research, the Research Study Coordinator 1 performs as the Research Study Coordinator for investigator-initiated research. The role assists faculty with clinical research study activities, including developing, submitting, and managing regulatory paperwork; submitting Institutional Review Board (IRB) applications and annual renewals; and preparing and maintaining study files and essential trial documents. This is a two-year grant-funded position located in Knoxville, Tennessee.

Requirements

Bachelor’s degree in a relevant health field; transcript required.
One year of relevant experience, or an associate’s degree and three years of relevant experience, or an equivalent combination of education, training, and experience totaling five years.
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 protocols, basic research principles, and the Federal Code of Regulations for clinical research studies.
Ability to manage multiple priorities.
Ability to interact with a diverse population.
Intermediate-level computer skills and ability to learn new software applications for electronic data capture programs.
Strong interpersonal and communication skills.

Responsibilities

Assist investigators with study design by reviewing proposals and determining methods suited to the study objectives.
Assist investigators with initial IRB submissions by gathering required collaboration agreements, key personnel documents, department approvals, funding information, IND information, drug or device specifics, and completing and uploading IRB applications into iMedRIS.
Assist investigators with IRB continuing reviews, including completing study status reports.
Prepare study-specific protocols, source documents and spreadsheets, drafts of required study logs, essential trial documents, and study files.
Assist investigators with the execution and coordination of GSM investigator-initiated research.
Assist with screening potential subjects; reviewing and documenting medical histories and concurrent medication lists; obtaining informed consent; coordinating on-campus study visits and procedures; collecting study data; and performing study assessments as needed, such as lab draws, questionnaires, and vital signs.
Establish and maintain contact with study participants and families, community agencies, and health care providers.
Assist investigators with managing and maintaining study-specific Master Trial Files and Essential Trial Documents.
Assist investigators and the Director of Research with coordinating Quality Assurance and Monitoring pathway audits.
Perform other duties as assigned.