We’re hiring! Clinical Research Specialist Opportunity
Are you passionate about pediatric nephrology and eager to contribute to groundbreaking research? We have an incredible opportunity for you! Our lab is seeking a dedicated and enthusiastic Clinical Research Specialist to join our team for the Biobank to Illuminate the Genomic basis of Kidney Disorders (BIGKiDs) study. This is a chance to make a significant impact in the lives of children with kidney diseases and contribute to advancing medical knowledge in the field.
As a Clinical Research Specialist your responsibilities will include:
Assists Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI coordinates preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
Recruits study participants for enrollment in clinical trials. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants, screens study participants for eligibility on the telephone, in the clinic and other settings as required. Completes follow up with study participants in prescribed settings as required.
Organizes study procedures and schedules study participants for study visits. Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
Completes record abstraction of source documents, conducts required study measurements and completes study Case Report Forms in accordance with best practice methods. Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries. Completes data entry as warranted.
Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB). Updates protocol and amendment changes.
Assists investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles.
