Job Summary

The Research Coordinator has general responsibility for managing clinical trials for the Clinical Trials Office. This includes responsibility for identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating, and following patients in clinical trials; coordinating therapy initiation and continuation; taking call for issues related to clinical trials; completing and filing necessary forms with internal and external departments and agencies as necessary; and maintaining records for patients enrolled in clinical trials.

Core Responsibilities and Essential Functions:

• Coordinates all facets of patient involvement in clinical trials.
• Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.
• Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines.
• Communicates with physician/office staff regarding scheduling protocol specific requirements.
• Attends patient visits and gathers protocol-specific information when required.
• Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate.
• Coordinates dispersement of protocol provided drug therapy.
• Ensures that Investigation Product chain-of-custody practices are instituted and documented. Maintains accurate records for patients enrolled on clinical trials.
• Communicates effectively with Research Assistants and other research staff.
• Gathers appropriate source documentation
• Submits required documentation within designated time frame.
• Provides proper documentation of eligibility, treatment and follow-up requirements.
• Provides accurate research information to physicians and sponsors.
• Maintains a current chart on each protocol patient.
• Enters patient visits into clinical trial database. Ensures regulatory guidelines are followed.
• Prepares research charts for monitoring visits and audits and assists with visits as required.
• Follows guidelines and timelines for reporting Adverse Events and Deviations.
• Maintains current protocol with revisions, amendments and current IRB approved informed consent.
• Ensures clinical trial and sponsor-required training is completed.
• Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required.
• Ensures that ongoing training during the course of a clinical trial is completed.
• Facilitates ongoing training for other team members, including investigators.
• Maintains current Human Research Participant Protection and Hazardous Material training. Assists with other departmental functions.
• Attends committee meetings as required.
• Attends functional team meetings and disseminates information.
• Assists with regulatory and billing functions, when required.
• Responsible for additional projects, as directed by the manager.

Schedule: Monday-Friday 8-5

Pay: $37-$47/hour

Location: Marietta, GA, 30060