Remote Clinical Research Operations Lead – Multi-Site Trials

Stanford University; Palo Alto (CA); Remote; USD 85,000 - 110,000; Full time

Benefits offered by this job

Remote work

Job summary

The Stanford Center for Clinical Research (CRH) at Stanford University seeks a Clinical Research Operations Specialist II to manage a large multi-site cardiovascular trial and provide live site support. This role serves as the primary contact for the sponsor and principal investigator.

Responsibilities include overseeing participant recruitment, data management, budget development, regulatory compliance, and mentoring staff, with a focus on timely communication and process improvements across

Qualifications

• Bachelor's degree in a related field and two years of clinical research experience or equivalent.
• Strong interpersonal skills and communication abilities.
• Proficiency in Microsoft Office and database applications.
• Experience with HIPAA, FDA regulations, IRB requirements and GCP.

Responsibilities

• Oversee subject recruitment and study enrollment goals and strategies.
• Manage data collection, reporting, and data analysis for multi-site trials.
• Develop project schedules, targets, and minutes for team meetings.
• Supervise and mentor new staff and students as assigned.
• Audit operations for regulatory compliance and monitor IRB submissions.
• Collaborate with investigators and sponsors; monitor serious adverse events.
• Advise on policy improvements and best practices.
• Develop study budgets and track milestones; invoice sponsors per contract.
• Ensure regulatory compliance and document readiness for FDA/IRB processes.
• Work with investigators to submit INDs to FDA when applicable.

Skills

Interpersonal skills

Microsoft Office

Database applications

Regulatory knowledge

Education

Bachelor's degree in a related field

Job description

The Stanford Center for Clinical Research (CRH) at Stanford University seeks a Clinical Research Operations Specialist II to manage a large multi-site cardiovascular trial and provide live site support. This role serves as the primary contact for the sponsor and principal investigator.

Responsibilities include overseeing participant recruitment, data management, budget development, regulatory compliance, and mentoring staff, with a focus on timely communication and process improvements across