Stanford University Clinical Trials Coordinator - 61836 Description The Clinical Trials Coordinator, Pediatric Dermatology, will assist with the management of studies that are dermatology based. On a daily basis, the Trials Coordinator will work closely with pediatric dermatology faculty at the Lucile Packard Children’s Hospital Campus. The Clinical Trials Coordinator, Pediatric Dermatology, is responsible for the overall management and implementation of assigned clinical research protocols in assuring compliance, efficiency, and the safety and wellbeing of trial participants. Responsibilities include the recruitment, screening and enrollment of study participants, including the informed consent process; assistance in scheduling diagnostic and research evaluation visits; interaction with patients; develop, edit, and implement Standard Operating Procedures for manufacturing, quality control, quality assurance along with research scientists. The Trials coordinator will schedule maintenance and calibrations for laboratory equipment to maintain compliance, order supplies for clinical study visits and laboratory supplies and reagents and keep an expense record for those purchases, and work with financial associate to report expenses to sponsors or agencies as required. The Trials Coordinator will design and implement multiple electronic databases for study data management, maintain data entry, and prepare reports for sponsors and grantors. Data management will include retrieving data; reporting, preparing and maintaining of files and Case Report Forms; and entering study-related data in databases. The Trials Coordinator will oversee patient compliance to study protocols, obtain information from patients regarding adverse events, and promptly document and report findings to the principal investigator and regulatory authorities. As applicable, the Coordinator will be responsible for co-developing study budgets, verifying billing statements and invoices, and working with Stanford staff and the study sponsors or their designated contract research organization for timely reimbursements Coordinator will meet with patients to obtain informed consent, gather appropriate documentation to ensure accurate data, and will follow up with research patients according to procedures in different trials. The Coordinator may also at times perform other departmental duties such as assisting with onsite visits and providing coverage for other members of the Pediatric Dermatology team. The Coordinator will always first and foremost protect the rights, safety and wellbeing of human subjects involved in the clinical trials. Manage all aspects of multiple clinical trials, including a complex large gene transfer clinical trial which requires complex interactions with the Food and Drug Administration (FDA) and knowledge about FDA requirements. Provide support to investigators for multiple clinical research efforts and work with multiple regulatory agencies including the Institutional Review Board, Biosafety Panel, Data Safety Monitoring Boards, and FDA. Recruit and communicate with patients for studies, develop study protocols, write and assist with writing grant proposals, conduct study patient visits along with investigators. Qualifications - This position requires a four-year college degree in the science or health care field along with 3 or more years of experience managing research projects. - Knowledge of FDA regulations, IRB requirements, and Good Clinical Practice is required. - Experience overseeing completion of complex regulatory requirements. - Must possess excellent oral and written communication skills, professionalism and poise in patient interactions, and outstanding customer service skills to deal with a wide variety of individuals. - Must be comfortable with computer software applications such as Microsoft Word, Excel, Outlook, Internet Explorer/Firefox, PowerPoint, Cerner/Epic, sponsor electronic data capture systems, as well as able to master Stanford’s Oracle financial system. Must be able to master new software quickly. - Must be able to work independently, take initiative to find and complete tasks needed, set priorities, anticipate needs, meet deadlines, and have intuition to coordinate administrative needs of multiple studies and multiple investigators. - Must be able to juggle many tasks in an efficient manner with frequent interruption by subject visits and calls, and have ability to handle numerous administrative and scientific tasks in a timely and efficient manner. - The Coordinator must have the ability to work effectively with a wide range of individuals and groups at all levels of authority. - A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail is also required. - This position requires superior follow-up skills. To apply, visit http://apptrkr.com/437226 or http://jobs.stanford.edu Stanford University is an affirmative action, equal opportunity employer.