"Clinical Research Coordinator 2"

The Division of Gastroenterology and Hepatology has a long tradition of major contributions in basic research, a new commitment to clinical and outcomes research, a track record of training fellows for academic careers, and a longitudinal commitment to providing care for patients with complex gastrointestinal and liver diseases.

Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

The Clinical Research Coordinator 2 (CRC2) will play a vital role in advancing these efforts by managing increasingly complex projects and assignments. This role primarily involves overseeing clinical studies and trials ranging from nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and Hepatitis B and D to celiac disease, inflammatory bowel disease (IBD), esophageal and gastrointestinal motility disorders, and microbiome studies. The CRC2 will independently manage all aspects of these studies, ensuring their successful execution and high-quality outcomes.

This CRC2 will also serve to recruit healthy donors to organize a Stanford Stool Bank that will enable a Fecal Microbiome Transplant (FMT Program). This project will be time-intensive and require recruitment and close follow up with stool donors. This CRC2 will also assist in microbiome studies involving dietary intervention in both healthy subjects and those with GI disease.

This is a hybrid eligible position.

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.

DESIRED QUALIFICATIONS:

• Knowledge of FDA regulations, IRB requirements, and Good Clinical Practice.
• Experienced in collaborating with healthcare professionals and research participants.
• Strong organizational skills, capable of working independently or in a team.
• Excellent problem-solving abilities with a proactive approach to optimizing processes.
• Skilled in working with diverse individuals across all authority levels.
• Proven ability to manage multiple tasks, set priorities, and work efficiently in fast-paced environments with attention to detail.

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 in 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.
• May require a valid California Driver’s License.

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