The Director of Clinical Research Operations provides strategic and operational leadership for the clinical research department. This position oversees regulatory compliance, financial performance, staff development, sponsor relationships, physician engagement, and overall growth of the research program.
The Director is responsible for ensuring studies are conducted safely, ethically, efficiently, and profitably while maintaining the highest standards of patient care and regulatory compliance.
Leadership
- Supervise Clinical Research Coordinators and research staff
- Hire, onboard, and train research employees
- Conduct performance evaluations
- Develop departmental policies
- Foster a collaborative culture
- Ensure adequate staffing
Operations
- Oversee all active studies
- Evaluate feasibility of new studies
- Develop department workflows
- Improve operational efficiency
- Manage study timelines
- Monitor enrollment metrics
- Ensure protocol compliance
Business Development
- Build relationships with sponsors and CROs
- Identify new study opportunities
- Expand therapeutic research offerings
- Increase patient enrollment
- Develop physician engagement strategies
- Represent the practice during sponsor visits
- Support marketing of the research program
Financial Management
- Develop departmental budgets
- Monitor study profitability
- Negotiate study budgets
- Review contracts with sponsors
- Ensure timely sponsor invoicing
- Track revenue
- Improve financial performance
- Monitor payment reconciliation
Regulatory Oversight
- Ensure GCP compliance
- Oversee regulatory submissions
- Prepare for FDA inspections
- Prepare for sponsor audits
- Maintain SOPs
- Oversee CAPA implementation
- Ensure training compliance
Quality Assurance
- Conduct internal audits
- Monitor protocol deviations
- Review informed consent documentation
- Implement quality improvement initiatives
- Ensure data integrity
- Maintain inspection readiness
Physician Collaboration
- Work closely with Principal Investigators
- Assist providers with study selection
- Ensure physician compliance
- Coordinate investigator meetings
- Support physician education
Qualifications
Required:
- Bachelor's degree (or equivalent experience)
- 5+ years clinical research experience
- 2+ years leadership experience
- Strong understanding of FDA regulations
- GCP expertise
- Budget management experience
Preferred:
- CCRP, CCRC, or ACRP-CP certification
- IRB experience
- Rheumatology experience
- Multi-site research experience
- Experience with study startup and feasibility (SIV/SQV)
- Business development experience
Benefits:
- 401(k)
- Health insurance
- Paid time off
Work Location: In person
