Research Study Coordinator 1-Research Center (Knoxville)

University of Tennessee•Knoxville, TN

20h•Onsite

About The Position

The Research Study Coordinator 1 performs Investigator-Initiated Research for Maternal Fetal Medicine, Neonatology, and High-risk Obstetrics. 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.

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 an equivalent combination of education, training, and experience to equal five (5) 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 protocol with an understanding of 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 with the ability to learn new software applications for various electronic data capture programs.
Ability to exhibit strong interpersonal and communication skills.

Responsibilities

Assists investigators with the design of Maternal Fetal Medicine, Neonatology, and High-risk Obstetrics related studies by reviewing and/or writing proposals using methods best suited to study objectives.
Assists investigators with the development and submission process for Institutional Review Board (IRB) approval including the collection of hospital collaboration agreements, key personnel documents, department approvals, funding source information, IRB application completion, and uploads in iMedRIS.
Coordinates operational components of retrospective research and survey-driven research for study-specific Investigator-Initiated research for Maternal Fetal Medicine, Neonatology, and High-risk Obstetrics.
Provides essential information to the GSM OB/GYN data coordinator, Physical Activity and Metabolism lab manager, or the Principal Investigator during the data analysis phase of Investigator-Initiated research.
Assists investigator with the IRB process for protocol amendments and/or adding or removing IRB approved personnel from an Investigation-Initiated Project; assists faculty with the IRB process for the IRB Adverse Events, Serious Adverse Events, and Protocol Deviations.
Assists in screening potential subjects, reviewing and documenting patient medical histories and concurrent medication, obtaining informed consent, coordinating study visits and procedures to be completed on campus, collecting study data, and performing study assessments if needed (lab draws, questionnaires, vital signs, etc.) for Investigator-Initiated Studies.
Establishes and maintains contact with study participants and families, community agencies, and health care providers.
Assists investigator with the management and maintenance of study-specific Master Study Files and Essential Study Documents.
Assists with the management and maintenance of Subject Source Documents.
Facilitates study-specific communication and meetings.
Performs other duties as assigned.