Remote Clinical Research Ops Lead for Multi-Site Trials

School of Medicine; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

Stanford Center for Clinical Research (CRH) is seeking a Clinical Research Operations Specialist II to oversee, coordinate, and manage a large multi-site clinical trial in cardiovascular medicine. The role requires live support for study sites, data management, and regulatory oversight across remote multisite operations.

You will collaborate with investigators and sponsors, monitor safety events, and drive process improvements while ensuring compliance with HIPAA, FDA, and IRB requirements.

Qualifications

• Bachelor's degree in a related field and two years of clinical research experience.
• Familiarity with regulatory requirements (HIPAA, FDA) and IRB.
• Strong communication and teamwork abilities.

Responsibilities

• Oversee subject recruitment and enrollment goals and strategies.
• Manage data collection, reporting, and data analysis processes.
• Develop project schedules, lead team meetings, and track milestones.
• Mentor staff and coordinate onboarding and evaluations.
• Audit operations for regulatory compliance and oversee IRB submissions.
• Collaborate with investigators and sponsors to monitor safety events and resolve queries.
• Identify and implement process improvements and best practices.
• Develop study budgets and manage invoicing per contract.
• Ensure regulatory compliance and prepare regulatory submissions.

Skills

Interpersonal skills

Data management

Project coordination

Regulatory knowledge

Communication

Education

Bachelor's degree in a related field

Tools

Microsoft Office

Database applications

Job description

Stanford Center for Clinical Research (CRH) is seeking a Clinical Research Operations Specialist II to oversee, coordinate, and manage a large multi-site clinical trial in cardiovascular medicine. The role requires live support for study sites, data management, and regulatory oversight across remote multisite operations.

You will collaborate with investigators and sponsors, monitor safety events, and drive process improvements while ensuring compliance with HIPAA, FDA, and IRB requirements.