"Clinical Research Coordinator Associate Fixed-term 1 year"

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 Associate (CRCA) Fixed-term 1 year to take on the responsibility of conducting clinical research and independently managing research projects for multiple PIs in the Regional Division. The CRC will be instrumental in overseeing research studies primarily focused on regional anesthesia and pain management in the perioperative period. We seek an enthusiastic and energetic individual to join in the management of research for the Regional Anesthesia Faculty Group. Research aims within this group include investigations of novel nerve block techniques, including how they impact sensory processing, postoperative pain, and opioid use, in the days-weeks after surgery.

Research activities include employing validated questionnaires and quantitative sensory testing tools for the accurate measurement of patient characteristics and clinical outcomes. Activities will also include preoperative assessment of patients to identify those at highest risk of pain and problematic opioid use after surgery, with the goal of preventing both pain and problematic opioid use after surgery in an individualized way. We conduct longitudinal, perioperative observational and interventional studies in surgical and chronic pain patients. Interventions test pharmacologic analgesics and regional anesthetic techniques, comparing standard and novel blocks. Research involves interacting with operative patients and healthy volunteers, working within clinical systems to implement self-reported psychosocial assessment, and performing quantitative sensory testing at the bedside or in the lab. Proficiency at analysis of data, manuscript preparation, and grant writing is valued but not required.

Because this research involves engaging with multiple PIs and collaborators in the division, professionalism, humor, problem-solving, and a pioneering spirit are appreciated. Strong communication skills, and a balance between independence and team spirit is essential.

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 OR environment. Regular collaboration with medical teams, including nurses and pharmacy staff, will be essential. The CRC will develop and maintain specialized databases, such as those tracking enrollment, quantitative sensory testing, 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 CRC 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 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. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.

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. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.

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:

• Work collaboratively with multiple Principal Investigators in the Regional Division of the Department of Anesthesia to coordinate and manage all aspects of assigned studies, from start-up through close-out.
• Serve as a primary liaison with study participants, sponsors, and regulatory agencies.
• Oversee the informed consent process, ensuring consent is obtained, documented, and managed in accordance with IRB and institutional guidelines.
• Develop, implement, and monitor participant recruitment and enrollment strategies to ensure timely and adequate enrollment; adjust strategies as needed.
• Schedule and coordinate study visits and procedures with participants, clinical staff, and laboratory personnel, including research tissue sample collection and processing.
• Collect, enter, and manage clinical, enrollment, and study intervention data; develop and maintain study databases using platforms such as REDCap and other tracking systems.
• Create and maintain study tools, databases, and documentation to support protocol adherence and regulatory compliance.
• Perform study-specific testing and collect data from timed and protocol-driven study interventions.
• Ensure compliance with Good Clinical Practice (GCP), IRB requirements, and applicable regulatory standards by regularly reviewing study procedures and documentation.
• Identify compliance gaps or protocol deviations and implement corrective actions as needed.
• Assemble study kits, schedule and attend study-related meetings, and support day-to-day study operations.
• Monitor individual participant expenditures and identify, report, and correct discrepancies or errors.
• Monitor participants for adverse events, report safety concerns to the Principal Investigator, and propose solutions to address participant safety issues.
• Prepare and provide regular study status updates to PIs, including recruitment metrics and reports required by the IRB or funding sources (e.g., quarterly reports).
• Maintain complete and accurate research records in accordance with institutional, sponsor, and regulatory requirements.
• Collect and prepare study data and documentation for internal and external audits; assist with monitor visits and site inspections, including presentations as needed.
• 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):

Two year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related 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.

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 $34.56 to $40.30 per hour.