Remote Clinical Research Operations Specialist II

Stanford University School of Medicine; United States; On-site; USD 70,000 - 90,000; Full time

Job summary

Stanford University School of Medicine is seeking a Clinical Research Operations Specialist II to manage a large, multisite, remote clinical trial in cardiovascular medicine. The role involves live support for study sites, data oversight, budgeting, and regulatory compliance, serving as the main contact for sponsor and PI.

The position emphasizes leadership, mentoring, and process improvements while ensuring participant safety and enrollment targets are met across sites.

Qualifications

• Bachelor's degree in a related field and two years of clinical research experience.
• Experience with HIPAA, FDA regulations, IRB requirements, and Good Clinical Practices.
• Proficiency with Microsoft Office and database applications.
• Knowledge of medical terminology.

Responsibilities

• Oversee subject recruitment and enrollment goals and promote participant retention.
• Oversee data management: organize, collect, report, and monitor data.
• Develop project schedules, targets, and lead team meetings; approve minutes.
• Supervise, train, and mentor staff, including performance evaluations.
• Audit operations for regulatory compliance and monitor IRB submissions.
• Collaborate with principal investigators and study sponsors; monitor adverse events.
• Develop and implement improvements to policies/processes; define best practices.
• Develop study budgets and track milestones; invoice sponsors according to contract.
• Ensure regulatory compliance and inspect study documents.
• Work with PI to submit INDs to FDA when applicable.

Skills

Interpersonal skills

MS Office & databases

Regulatory knowledge (HIPAA, FDA, IRB)

Medical terminology

Education

Bachelor's degree in a related field

Job description

Stanford University School of Medicine is seeking a Clinical Research Operations Specialist II to manage a large, multisite, remote clinical trial in cardiovascular medicine. The role involves live support for study sites, data oversight, budgeting, and regulatory compliance, serving as the main contact for sponsor and PI.

The position emphasizes leadership, mentoring, and process improvements while ensuring participant safety and enrollment targets are met across sites.