Clinical Research Coordinator

Clinical Research Coordinator 2 at Stanford University summary:

The Clinical Research Coordinator II at Stanford University manages multiple neuro-oncology clinical studies, overseeing participant recruitment, data collection, regulatory compliance, and team supervision. The role requires coordination with principal investigators and sponsors to ensure high-quality research results and adherence to FDA and IRB regulations. The position demands strong organizational, interpersonal, and scientific skills, with a preference for candidates experienced in neurosurgery/oncology clinical trials and research protocols.

Stanford University’s Department of Neurosurgery is seeking a Clinical Research Coordinator II (CRCII) 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. Studies may include drug/ device trials, longitudinal natural history studies, and other PI-initiated projects dealing with pediatric and adult neuro-Oncology treatments.

The CRCII will directly coordinate 2 or more clinical studies, supervise and delegate tasks for 5 or more studies, and work under the close direction of the manager (CRM), regulatory specialist and principal investigator(s). The CRCII will support industry, federal and grant funded clinical research studies. The CRC II will manage 1-3 CRCAs and will be responsible for training, assigning tasks and reviewing their work.

This CRC II position is a full-time position, and a commitment of at least two years is required. CRC IIs are expected to be available up to 5 days a week on site. This position may require occasional evening and weekend hours.

Interested candidates, please apply with your resume and a cover letter. Please describe your background, interests, and future goals in the cover letter.

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 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.
• Hybrid Work Agreement.

* Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• Neurosurgery/ Oncology clinical trial coordination experience working with adults and children.
• Investigator Initiated clinical trial coordination experience.
• Experience with local and single-IRB submissions.
• Experience with protocol drafting and IND/IDE documents.
• Experience working with various databases such as REDCap, Oncore and various EDC systems.
• Knowledge of data-related research and…