"Clinical Research Coordinator 2 (CRC2) – Fixed-term 2 years"

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 of Anesthesiology, Perioperative, and Pain Medicine is in search of a Clinical Research Coordinator 2 (CRC2) – Fixed-term 2 years to take on the responsibility of conducting clinical research and independently managing complex projects. The CRC2 will be instrumental in overseeing research studies primarily focused on surgical and ICU patients. Specific studies include evaluation of novel monitoring devices and both investigational drug and device studies focusing on novel treatments for acute kidney injury. The CRC2 will collect key study measures, maintaining the integrity of critical care research. The coordinator will be responsible for managing data related to study outcomes, ensuring that all source documents are complete and that participants adhere to study protocols, especially those specific to the ICU and OR environment. Regular collaboration with medical teams, including nurses and pharmacy staff, will be essential. The CRC2 will develop and maintain specialized databases, such as those tracking enrollment, ICU outcome metrics (e.g., ventilator days, organ failure scores), and lab specimen data. They will regularly evaluate data collection processes, identifying areas for improvement to ensure the accuracy and efficiency of study related data capture. Moreover, the CRC2 will oversee quality control, ensuring that team members’ data collection complies with Good Documentation Practices (GDP) and the ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate). Their role is crucial in maintaining the study's compliance, accuracy, and overall success in ICU patient research.

At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care.

Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives.

The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.

For more information on our department, please see our website: https://med.stanford.edu/anesthesia.html

Duties include:

• 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 document 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.
• May require working extended or unusual hours based on research requirements and business needs. This may include weekends and early or late hours. These requirements may be known several days in advance and can be discussed.

* - Other duties may also be assigned

EDUCATION & EXPERIENCE (REQUIRED):

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 (REQUIRED):

• Strong interpersonal skills
• Proficiency with 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.

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 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.

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 value for 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 but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

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.

The expected pay range for this position is $86,248 to $100,158 per annum.