Clinical research coordinator to assist with all aspects of research including protocol review, site preparation, informed consent, subject recruitment, data collection and completion of CRFs, follow-up visits, reporting of AEs and SAEs, deviations, and queries. Maintains regulatory binders. Assists the PI in the consent process, screening, scheduled visits. Must be current on Good Clinic Practice, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.
Assist the PI in all aspects of conducting the clinical study following the FDA and Sponsor regulations and guidelines. Ensures the safety and welfare of research participants.
Design and organize a workflow system for research-related activities.
Comprehension of the Center’s active clinical trials. Able to organize the conduct of the study and maintain the organizational tools to run the study accurately and following GCP.
Develop source documents and logs, when needed.
Actively screen for potential research participants using inclusion/exclusion criteria. Scheduled visits according to the protocol’s schedule of events.
Actively involved with the training of other research staff personnel and pertinent clinic staff
Perform the informed consent process with potential study participants. Answer any questions while conducting the informed consent with the guidance of the PI. Document process completely and accurately.
Conduct all research visits
Document and report all AEs, SAEs, unanticipated problems, and deviations to the sponsor and IRB following Federal regulations.
Complete all required CRFs accurately and completely. Able to abstract data from clinic charts and hospital records.
Receive and document receipt of investigational product and store product following sponsor guidelines.
Dispense and return all investigational supplies and maintain records of such.
Work with the sponsor during site initiation visits, routine monitoring visits, close-out visits, and audits. Resolve sponsor-generated queries.
Perform assessments as needed including lab draws, EKG, vitals.
Atlanta Neuroscience Institute stands as the foremost neurological medical center in Atlanta, GA, with a dedicated focus on conditions such as Multiple Sclerosis, Parkinson's Disorder, Epilepsy, Alzheimer's, and General Neurology. Our state-of-the-art facility provides comprehensive clinical care, pioneering research, and supportive social services, positively impacting the lives of individuals affected by these conditions across the nation.