Job Title

Summary The Research Coordinator will be responsible for safe and effective conduct of clinical trials from start to finish, ensuring visits and procedures are conducted in accordance with the protocol, site standard operating procedures (SOPs), ICH-GCP principles, and regulatory requirements of the IRB and more. Supervisory Responsibilities This position does not have supervisory responsibility but will provide guidance to employees and/or assist with orientation and training of new employees of the work group. Primary Duties and Responsibilities * Correspond with IRB regarding study start-up, maintenance, study documents, and report safety data as appropriate. * Review protocol to ensure thorough and accurate data collection and procedures are conducted according to study protocol. * Conduct chart reviews and interviews to prescreen prospective subjects for studies and schedule screening visits. * Conduct informed consent discussions in accordance with ICH/GCP principles. * Maintain source documents and regulatory documentation for clinical trials. * Carry out study visits and collect study data in accordance with study protocol Maintain regular contact with subjects for thorough safety data collection and ensure study visits are scheduled and carried out in accordance with protocol. * Present adverse and serious adverse events to Principal Investigator / sponsor / IRB as appropriate. * Run and review reports in electronic health records (EHR) to gather data about study feasibility and for pre-screening activities. * Create and maintain standard operating procedures for the site. * Report research visa expenditures to manager. * Ensure adequate staff training and maintenance of site equipment. * Schedule and facilitate monitoring visits. * Ensure subjects are compensated as outlined in the ICF. * Clean and maintain equipment and instrumentation in good working condition; perform minor repairs and adjustments as needed. * Ensure that services and products are appropriate to meeting patient needs and work is performed in an efficient, timely and accurate manner. * Perform work in compliance with company policy, department procedures and regulatory requirements, including HIPAA and OSHA. Secondary Functions * Drawing blood, centrifuging, and freezing blood samples. * Preparing and shipping study samples. * Other duties which may be necessary or desirable to serve the patient and support the success of the department or the company overall.