"Clinical Research Coordinator 2"

The Stanford Prevention Research Center (SPRC) is a consortium of renowned experts who are world leaders in investigating chronic disease prevention and management. Their work focuses on identifying practical, science-based solutions for addressing some of society's most pervasive and burdensome health issues, such as obesity, diabetes, hypertension, and heart disease.

As an internist and epidemiologist in the Center, Randall Stafford, MD, PhD, is the Director of the Center's Program on Prevention Outcomes and Practices. He and his research team focus on creating healthcare models that emphasize effective health communication and patient empowerment. His mission is to improve population health outcomes in the U.S. and globally through research that facilitates the development and broad dissemination of effective, efficient, patient-centered, and evidence-based healthcare strategies. Examples of these innovations include team-based care, patient self-management, health policy strategies, use of AI, and leveraging digital health technology.

Dr. Stafford and his co-investigators seek an experienced and enthusiastic Clinical Research Coordinator 2 to join a multidisciplinary team conducting an NIH-funded clinical trial testing the effectiveness of a digital decision-making app in older people with advanced heart failure considering placement of an implantable cardioverter-defibrillator (ICD).

The Clinical Research Coordinator 2 will manage multiple aspects of the clinical trial at Stanford, while also contributing to management of two additional clinical sites. Major tasks will include:

• Clinical trial preparation, including human subjects and REDCap database construction
• Training of participating clinicians
• Participant recruitment and randomization
• Participant data collection and follow-up scheduling
• Protocol integrity, outcomes, and data monitoring
• Coordinating the three clinical sites
• Helping to disseminate the ICD app
• Contributing to the team's broad research mission

This is a hybrid eligible position. This is a two-year fixed-term 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:

• 4+ years of experience coordinating investigator-initiated clinical trials within an academic medical center.
• Cardiology, medical device, and/or decision-making clinical trials coordination experience.
• Enjoy working independently with older adults and their families.
• Experience working with clinical research databases, particularly REDCap or similar platforms.
• Experience with local and single-IRB requirements and submissions.
• Proficiency in Spanish or Mandarin would be a bonus.

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.