The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to advance impactful clinical research through quality operations.

In collaboration with the Division of Infectious Diseases, SCCR is seeking a Clinical Research Coordinator-II (CRC-II) to perform duties related to the coordination of clinical research studies, including COVID-19, flu vaccines, and other infectious disease clinical trials. This is a participant facing role which will require the candidate to be primarily onsite for the conduct and execution of all study related tasks and procedures.

The CRC-II will work closely with the PI and Clinical Research Manager (CRM) in a dynamic environment, and be responsible for supporting multiple staff members, including coordinators and data managers. The CRC-II will work on multiple studies to develop recruitment and retention strategies, oversee study operation and conduct, oversee regulatory compliance and financial logistics, and ensure overall progress on the project. The position will report project progress to the team and trouble-shoot barriers. Outstanding communication and organizational skills, the ability to proactively manage challenges, a strong grounding/background in clinical research, and attention to detail are qualities desired in a successful candidate.

At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply!

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.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.