Clinical Research Associate​/Coordinator

** Job Summary
** The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research.

The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact.

Principal Duties and Responsibilities:

All duties will be performed under general supervision by the Clinical Research Manager.
The following clinical duties will be performed:

· Assist clinical team in screening potential patients for study participation    
· Obtain informed consent for sample and data collection protocols    
· Schedule all protocol required tests and procedures    
· Coordinate patient appointments with physicians, nurses, and all test areas    
· Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers    
· Prepare pre-visit communication for providers to ensure required assessments are completed and documented    
· Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation    
· Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition    
· Coordinate, obtain, process, and ship protocol required tissue samples    
· Ensure collection and processing (e.g. spin/separate/freeze) and storage of all required correlative research blood and tissue samples    
· Administer quality of life assessments as required for individual studies      The following data management responsibilities will be performed:

· Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria    
· Enroll patients as required by the study sponsor and internal enrollment monitor team    
· Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance    
· Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.

· Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations    
· Maintain research charts and/or electronic files for all enrolled patients    
· Ensure adequate source documentation is in place for all data reported    
· Resolve data queries issued by the sponsor    
· Obtain protocol clarifications from the study sponsor and communicate information to the research team    
· Schedule and prepare for monitoring visits with sponsors    
· Facilitate the request and shipment of archival pathology samples    
· Organize and prepare for internal and external audits    
· Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies      The following regulatory duties may be performed:

· Maintain and organize study specific regulatory binders    
· Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB    
· Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study    
· Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor…