Research Study Coordinator- Research Center (Knoxville) bei UT Health Science Center BU
UT Health Science Center BU · Knoxville, Vereinigte Staaten Von Amerika · Onsite
- Junior
- Optionales Büro in Knoxville
Market Range: 08
Hiring Salary: $21.69/Hourly
JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Research Study Coordinator for University of TN Knoxville- Graduate School of Medicine (UTK/GSM) assists the faculty with clinical research study activities including but not limited to the submission and management of regulatory paperwork, the submission of Institutional Review Board (IRB) applications and annual renewals, preparation and maintenance of study files and essential study documents. This position coordinates the operational and implementation of study protocols.
Responsibilities
- Assists investigator with the execution and coordination of UTK/GSM collaborative Investigator-Initiated Clinical Research.
- Assists UTK/GSM investigators with the design of studies by reviewing proposals to determine methods best suited to study objectives.
- Assists investigators with the development and submission process for (IRB) approval including the collection of hospital collaboration agreements, key personnel documents, department approvals, funding source information, and IRB application completion.
- Assists investigators with the development of data extraction sheets and the process of data extraction from Electronic Medical Records (EMR) or Investigator-Initiated Studies and assists in developing relational databases for tracking study subjects
- 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.
Qualifications
EDUCATION: Bachelor’s Degree in a relevant health field. (TRANSCRIPT REQUIRED)
EXPERIENCE: 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.
KNOWLEDGE, SKILLS, AND ABILITIES:
- 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.
- Intermediate-level computer skills with the ability to learn new software applications for various electronic data capture programs.
- Understanding complex diagnoses and procedures.
