Clinical Research Coordinator 2 (Fixed-term 2 years)

Stanford University; Palo Alto (CA); On-site; USD 84,856 - 97,021; Full time

Job summary

Stanford University seeks a Clinical Research Coordinator 2 (CRC2) to coordinate a dynamic portfolio of complex clinical trials in critical care and operating room settings. You will recruit, enroll, and follow participants, collaborate with PIs, nurses, and pharmacy staff, and ensure data integrity throughout the study lifecycle.

The role involves managing regulatory documents, IRB submissions, and adherence to FDA/ICH guidelines. Some duties may require extended hours to meet study needs.

Qualifications

• 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.

Responsibilities

• Lead subject recruitment and enrollment strategies.
• Oversee data management for research projects and analyze data.
• Collaborate on project schedules, targets and accountability.
• Train and mentor staff and assist with evaluations.

Skills

EMR systems

Inpatient trials

Participant recruitment

Interpersonal skills

MS Office

Regulatory knowledge

Medical terminology

Education

Bachelor's degree + 2 yrs clinical research

Job description

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 coordinate a dynamic portfolio of multiple complex clinical trials in various stages of the study life-cycle, from start-up through closeout. Participant populations are primarily adult patients in critical care and operative spaces, and will require long‑term outpatient follow‑up. The evolving study portfolio is primarily industry‑sponsored and includes research on treatments for Sepsis, Acute Respiratory Distress Syndrome, and Acute Kidney Injury. The CRC2 will participate in the identification, recruitment, and enrollment of participants. Trial design will sometimes require unusual work hours, including nights and weekends. The CRC2 will collaborate with other team members to collect key study measures, maintaining the integrity of critical care research. The CRC2 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.

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

• 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, 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.
• May require working extended or unusual hours based on research requirements and business needs. This may include weekends and early or late hours.

Qualifications

Desired Qualifications

• Experience coordinating complex industry‑sponsored clinical trials in the 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, 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, aerosols, 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.

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).

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 to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.