JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: 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 design studies by reviewing proposals to determine best-suited methods for study objectives.

Assist investigators with the collection and submission process for initial Institutional Review Board (IRB) submissions including the collection of hospital collaboration agreements, key personnel documents, department approvals, funding source information, Investigational New Drug (IND) information, Drug(s)/Device(s) specifics, and IRB application completion and upload into iMedRIS.

Assists investigator with the IRB Continuing Review process that includes the completion of study status reports.

Prepares study-specific protocols, source documents/spreadsheets, drafts of required study logs and essential trial documents, and prepares files.

Assists investigator with the execution and coordination of GSM Investigator-Initiated Research.

Assists in screening potential subjects, reviewing and documenting patient medical histories and concurrent medication lists, obtaining informed consent from patients, 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 Trial File and Essential Trial Documents.

Assists investigators and the Director of Research with the coordination of Quality Assurance and Monitoring pathway audits.

Performs other duties assigned.

EDUCATION: Bachelor’s Degree in 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 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.