Senior Clinical Research Program Lead – Multi-site Trials

Stanford Reglab

California

On-site

USD 140,000 - 165,000

Full time

4 days ago
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Job summary

The Childhood Research Obesity Prevention Lab at Stanford University is seeking a Senior Clinical Research Manager to lead complex, multi-site clinical studies and supervise research staff.

You will oversee regulatory compliance, budget management, data operations, and training of team members, with a focus on high-quality patient-centered research in pediatric populations. On-site presence in California is required.

Qualifications

  • Bachelor's degree in related field and five years of clinical research experience; Master's degree preferred.
  • Minimum of three years of demonstrated managerial experience.
  • Knowledge of HIPAA, FDA regulations, IRB requirements and Good Clinical Practices.
  • On-site work required, five days a week.

Responsibilities

  • Hire, orient, train staff and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials in patient-centered and community-based partnerships.
  • Oversee study protocols and operating procedures; educate research staff on policies and processes.
  • Oversee recruitment and retention of participants for long-term clinical trials and develop consent forms for IRB approval.
  • Coordinate protocol submissions and renewals to IRB, FDA and other regulators; manage renewals and regulatory filings.
  • Audit laboratory and other operations to ensure regulatory compliance; drive corrective actions.
  • Lead grant development and manage budgets; liaise with sponsors and department accounting.
  • Lead committees and represent the program in internal/external forums.
  • Engage in outreach and networking to promote research.
  • Assist with data analysis and manuscript preparation.

Skills

Excellent oral and written commuicatio
Attention to detail
Pediatric behavioral research
Multi-site randomized trials
Mentoring and supervision
Research auditing
Project management

Education

Bachelor's degree in related field
Master's degree preferred

Tools

REDCap Cloud
EPIC
Microsoft Office

Job description

The Childhood Research Obesity Prevention Lab at Stanford University is seeking a Senior Clinical Research Manager to lead complex, multi-site clinical studies and supervise research staff.

You will oversee regulatory compliance, budget management, data operations, and training of team members, with a focus on high-quality patient-centered research in pediatric populations. On-site presence in California is required.

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