Research Study Coordinator -Research Center; Knoxville

Research Study Coordinator 1-Research Center (Knoxville)

Job Description

THIS POSITION IS LOCATED IN KNOXVILLE, TN

Under the direction of the GSM Director of Research, the Research Study Coordinator 1 performs as the Research Study Coordinator for Investigator-Initiated Research. This position assists the faculty with clinical research study activities including but not limited to the development, submission and management of regulatory paperwork, the submission of Institutional Review Board (IRB) applications and annual renewals, and preparation and maintenance of study files and essential trial documents.

• Assists investigators with the development of study designs by reviewing proposals to determine best‑suited methods for study objectives.
• Assists investigators with the IRB submission process including collection of hospital collaboration agreements, key personnel documents, departmental approvals, funding source information, IND information, drug/device specifics, and uploading IRB application into iMedRIS.
• Assists with the IRB Continuing Review process including completion of study status reports.
• Prepares study‑specific protocols, source documents/spreadsheets, study logs, and essential trial documents.
• Assists with execution and coordination of GSM Investigator‑Initiated Research.
• Assists in screening potential subjects, reviewing and documenting patient medical histories, concurrent medication lists, obtaining informed consent from patients, coordinating study visits and procedures on campus, collecting study data, and performing study assessments as needed.
• Establishes and maintains contacts with study participants, families, community agencies, and health care providers.
• Manages and maintains the Master Trial File and Essential Trial Documents.
• Co‑ordinates Quality Assurance and Monitoring audits.
• Performs other duties assigned.

Education
:
Bachelor’s Degree in a relevant health field (TRANSCRIPT REQUIRED).

Experience
:
One year of relevant experience; OR Associate’s Degree plus three years of relevant experience; OR an equivalent combination to equal five years.

• Create and maintain extensive medical records on clinical research subjects.
• Understand hospital policies and procedures, medical records documentation, and HIPAA regulations.
• Know the research protocol with an understanding of Basic Research Principles and federal regulations for clinical research studies.
• Manage multiple priorities.
• Interact with a diverse population.
• Intermediate-level computer skills with the ability to learn new software applications for electronic data capture programs.
• Strong interpersonal and communication skills.

Entry level

Full‑time

Research, Analyst, and Information Technology

Higher Education

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