The Clinical Research Site Operations & Optimization Consultant will serve as a strategic advisor responsible for evaluating and strengthening the operational infrastructure supporting clinical research across CVAUSA practices.
This consultant will assess current research operations, policies, workflows, and site readiness across multiple locations and provide recommendations to improve efficiency, scalability, and regulatory compliance. The role will focus heavily on reviewing existing policies and procedures, identifying operational gaps, and developing standardized processes that enable practices to successfully conduct industry-sponsored clinical trials.
Working closely with CVAUSA research leadership, practice administrators, and site research teams, the consultant will help design and implement operational frameworks that support high-performing clinical research programs across a growing multisite network.
This position is well suited for an experienced clinical research operations professional who enjoys evaluating complex systems, building scalable processes, and guiding organizations through operational improvements.
Key Responsibilities
Operational Assessment & Program Evaluation
- Conduct comprehensive assessments of research operations across CVAUSA practices, including infrastructure, staffing models, workflows, and compliance processes.
- Review existing policies, procedures, and standard operating practices to identify gaps, inefficiencies, or opportunities for improvement.
- Evaluate site readiness for industry-sponsored clinical trials and identify operational barriers that may impact study execution.
Policy & Procedure Development
- Develop and revise research policies, procedures, and operational guidelines to support consistent, high-quality research execution across the network.
- Create standardized operating procedures (SOPs) aligned with Good Clinical Practice (GCP), regulatory requirements, and sponsor expectations.
- Design scalable operational frameworks that can be implemented across both new and experienced research sites.
Research Program Optimization
- Recommend operational improvements to enhance efficiency across the full research lifecycle, including feasibility, startup, enrollment, study execution, and closeout.
- Identify opportunities to improve participant identification, recruitment processes, and retention strategies.
- Support the development of sustainable research programs within community-based cardiology practices.
Operational Strategy & Implementation
- Partner with CVAUSA research leadership to prioritize operational improvements and guide implementation strategies.
- Provide subject-matter expertise related to clinical research operations, site startup, and regulatory compliance.
- Develop tools, templates, and operational playbooks that support consistent execution across the network.
Stakeholder Collaboration
- Work collaboratively with practice leadership, research coordinators, and administrative teams to implement operational improvements.
- Provide guidance and operational recommendations to support practices participating in clinical research.
- Serve as a trusted advisor to CVAUSA leadership on research operational strategy.
Qualifications
Required
- Bachelor’s degree required.
- 7+ years of experience in clinical research operations or clinical trial management.
- Strong understanding of industry-sponsored Phase II–IV clinical trials.
- Demonstrated experience evaluating or improving research site operations, workflows, or processes.
- Experience developing or implementing research policies, procedures, or operational frameworks.
- Strong project management and organizational skills.
- Ability to work independently while advising multiple stakeholders across a distributed network.
- Willingness to travel nationally approximately 25–50%.
Preferred
- Experience working with multisite clinical research networks.
- Experience supporting community-based or private practice research programs.
- Background in cardiovascular clinical research.
- Experience implementing operational improvement frameworks (Lean, Six Sigma, or similar).
Key Attributes
- Strategic and analytical thinker with strong problem-solving skills.
- Ability to evaluate complex operational environments and recommend practical solutions.
- Excellent communication and relationship-building abilities.
- Comfortable working in evolving and rapidly growing research environments.
