Clinical Research Coordinator 2

Job Description The Emmanuel Mignot Lab at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. Job Description The Emmanuel Mignot Lab at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. Desired Qualifications 3+ years of experience working in Sleep Medicine clinical trials. Experience with clinical trial study start-up and close-out activities. Previous experience serving as a study lead for a clinical trial that underwent an FDA audit. Direct participation and experience supporting an FDA audit. Strong knowledge and experience maintaining Investigator Site Files (ISF) and ensuring proper documentation and organization. Strong understanding of clinical trial documentation, regulatory requirements, and study compliance. Knowledge of sleep medicine disorders Experience participating in FDA audits Experience training and supervising a group of at least four Clinical Research Assistants (CRCAs) Experience participating in study start-up and closeout activities Experience recruiting and retaining complex patient populations in clinical trials Experience using Electronic Data Capture (EDC) systems and vendor portals Experience performing ECGs PHYSICAL REQUIREMENTS* Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. Working Conditions Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. Responsibilities Core Duties Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions. Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. Minimum Education And Experience Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. Knowledge, Skills And Abilities Strong interpersonal skills. Proficiency in Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology. Certificates And Licenses Required Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. Drivers License Requirements Must possess and maintain a valid California non-commercial Class C Driver's License. Ability to drive day or night. When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements. #J-18808-Ljbffr