Clinical Research Coordinator 2 (Fixed-term 2 years)

Overview The Department of Anesthesiology, Perioperative, and Pain Medicine at Stanford University School of Medicine seeks a Clinical Research Coordinator 2 (Fixed-term 2 years) to coordinate a dynamic portfolio of complex clinical trials in various stages of the study life-cycle. Participants are primarily adult patients in critical care and operative spaces, with long-term outpatient follow-up. The portfolio is primarily industry-sponsored and includes research on treatments for Sepsis, Acute Respiratory Distress Syndrome, and Acute Kidney Injury. Trial design may require unusual hours, including nights and weekends. The CRC2 will work with team members to collect key study measures and maintain data integrity, ensure source documents are complete, and ensure participants adhere to study protocols, particularly in ICU and OR environments. Regular collaboration with medical teams, including nurses and pharmacy staff, is essential. Note: This description reflects the responsibilities and qualifications for the role; it does not include administrative or application-process content. Responsibilities Lead subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee and contribute to data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Collaborate on project schedules, targets, measurements, and accountabilities, as assigned. Train and/or mentor new staff or students, potentially including hiring, preparing or assisting with 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 budgets with staff and principal investigators, identifying standard of care versus study procedures. Track patient and study milestones and invoice sponsors according to study contracts. Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with principal investigators to ensure Investigational New Drug applications are submitted to the FDA when applicable and ensure IRB renewals are completed. May require working extended or unusual hours based on research requirements and business needs, including weekends and early or late hours. * - Other duties may also be assigned Desired Qualifications Experience coordinating complex industry-sponsored clinical trials in critical care and OR settings. Experience processing and shipping human biological samples in a laboratory environment. Experience interacting with healthcare professionals in a critical care environment. Education & Experience (Required) Bachelor’s degree in a related field and a minimum of two years of experience in clinical research, or an equivalent combination of education and relevant experience. Knowledge, Skills and Abilities (Required) Experience navigating EMR systems Experience coordinating inpatient clinical trials Experience recruiting participants and obtaining informed consent in a hospital setting Strong interpersonal skills Proficiency with Microsoft Office and database applications Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices Knowledge of medical terminology Certifications & Licenses Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 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 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 their job. Working Conditions Position may require work in areas with hazardous materials and exposure to chemicals, aerosols, blood, body fluids 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. Work Standards Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including the personnel policies and other policies in the University’s Administrative Guide. The expected pay range for this position is $84,856 to $97,021 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered will be determined based on factors such as scope and responsibilities, qualifications, departmental budget, internal equity, geographic location, and external market pay for comparable jobs. The Cardinal at Work website provides information on Stanford’s benefits and rewards; specifics about the rewards package for this position may be discussed during the hiring process. School of Medicine, Stanford, California, United States We are an equal opportunity employer and value diversity. This description reflects the essential functions of the job but is not intended to be an exhaustive list of responsibilities or qualifications. #J-18808-Ljbffr