Clinical Research Coordinator

Overview

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education. The department is in search of a Clinical Research Coordinator 2 (CRC2) – Fixed-term 2 years to conduct clinical research and independently manage complex projects.

The CRC2 will oversee research studies primarily focused on surgical and ICU patients, including evaluation of novel monitoring devices and investigative drug and device studies addressing novel treatments for acute kidney injury. The role involves collecting key study measures, maintaining data integrity, managing study data, ensuring source documents are complete, and ensuring participants adhere to study protocols, especially in ICU and OR environments.

Regular collaboration with medical teams, including nurses and pharmacy staff, will be essential. The CRC2 will develop and maintain specialized databases (e.g., enrollment, ICU outcome metrics such as ventilator days and organ failure scores, and lab specimen data). They will evaluate data collection processes for accuracy and efficiency and oversee quality control to ensure compliance with Good Documentation Practices (GDP) and ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate).

The role is crucial to maintaining the study’s compliance, accuracy, and success in ICU patient research.

At Stanford University School of Medicine, our work touches lives today and tomorrow through education, research, and health care, advancing health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether in departments with faculty or units that support the school, staff are part of teams that propel us toward the future of medicine and Precision Health.

Stanford values excellence and fosters innovation, collaboration, and lifelong learning. The university offers career development programs, competitive pay, and benefits designed to increase financial stability and support healthy, fulfilling lives. Stanford is an award-winning employer providing an exceptional setting for professionals seeking to advance their careers.

The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity within our department. For more information, please see our website: (Use the "Apply for this Job" box below)..html

• Oversee subject recruitment and study enrollment goals. Develop 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; extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities. Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, including potential hiring, preparing or assisting with performance evaluations, and related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, to ensure regulatory compliance; lead 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 investigator, distinguishing standard of care from study procedures; track patient and study milestones and invoice sponsors per contract.
• Ensure regulatory compliance; regularly inspect study documents to maintain ongoing compliance.
• Work with the principal investigator to submit Investigational New Drug applications to the FDA when applicable; ensure Institutional Review Board renewals are completed.
• May require extended or unusual hours based on research requirements and business needs; hours may include weekends and early/late times and can be discussed in advance.
• Other duties may also be assigned.

Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

• Strong interpersonal skills
• Proficiency with Microsoft Office and database applications
• Experience with research protocols and regulatory bodies including HIPAA, FDA regulations,…