Clinical Research Coordinator 2, Abdominal Transplantation (Hybrid Opportunity)

Stanford University • Stanford, CA

50d • Hybrid

About The Position

From benchtop research to international programs, the Department of Surgery provides exceptional patient care, delivers outstanding undergraduate and graduate education, and furthers the field of surgery through innovative basic science and clinical research. We are seeking a Clinical Research Coordinator 2 (CRC) to oversee a combination of 4 studies for four multiple PIs in the Division of Abdominal Transplantation, Department of Surgery, and Transplant Nephrology. The CRC will conduct clinical research and work independently on progressively more complex projects/assignments. Please visit the following link for more information about the Division of Abdominal Transplantation, https://transplantation.stanford.edu/.

Requirements

• 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 or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.

Nice To Haves

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
• May require a valid California Driver's License.

Responsibilities

• 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.
• Other duties may also be assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Number of Employees: 5,001-10,000 employees