Director of Clinical Operations - Clinical Research

Job Description

Job Description

Director of Clinical Operations

Position Summary

The Director of Clinical Operations is responsible for the day-to-day operational performance of a multi-site clinical research network. This role oversees site operations, study execution, enrollment performance, and operational consistency across multiple clinical research locations.

The Director will work closely with site leadership to ensure clinical trials are conducted efficiently, in compliance with regulatory requirements, and aligned with organizational performance goals. This position will also support the development and implementation of scalable operational systems and processes that enable consistent and effective clinical research operations.

This is a hands-on operational leadership role requiring regular engagement with site teams to identify and resolve operational challenges, strengthen workflows, and drive consistent study performance.

The Director will collaborate closely with the Medical Director and executive leadership to ensure alignment between clinical oversight, study execution, and operational performance.

Key ResponsibilitiesClinical Site Operations

• Oversee day-to-day operational performance across multiple clinical research sites.

• Ensure consistency across sites, including workflows, staffing models, and study execution standards.

• Monitor key operational metrics, including enrollment, screening, visit completion, and study timelines.

• Identify operational gaps and implement process improvements to enhance site performance.

Study Execution

• Ensure clinical trials are conducted in compliance with ICH-GCP, FDA regulations, applicable regulatory requirements, and internal SOPs .

• Support site readiness for newly activated studies.

• Monitor study progress, including enrollment milestones and protocol adherence.

• Identify operational risks and implement mitigation strategies to maintain study performance.

Enrollment & Recruitment Collaboration

• Partner with patient recruitment leadership to support enrollment success across clinical research sites.

• Monitor recruitment metrics, including lead flow, screening conversion, and randomization rates.

• Identify operational barriers to enrollment and implement corrective strategies.

Compliance & Quality

• Promote a strong culture of regulatory compliance and operational quality.

• Ensure sites remain prepared for sponsor monitoring visits, audits, and regulatory inspections.

• Collaborate with regulatory and quality teams to ensure adherence to SOPs, protocols, and applicable regulations.

Operational Infrastructure

• Develop and implement standardized operational processes across the clinical research network.

• Support the implementation of operational dashboards and performance reporting tools.

• Establish systems and processes that enable scalable operations across multiple clinical sites.

People Leadership

• Provide operational oversight and support to site managers and clinical research teams.

• Establish performance expectations and KPIs for operational teams.

• Support staff development, training, and adoption of operational best practices.

• Foster a collaborative, accountable, and performance-driven culture across the research network.

Site Engagement & Operational Support

• Maintain regular engagement and presence at clinical research locations to support site teams.

• Work directly with site leadership to resolve operational challenges and bottlenecks.

• Support sites during study start-up and enrollment ramp-up phases.

Network Growth & Expansion

• Support operational planning for new site launches and network expansion.

• Assist executive leadership in preparing operational infrastructure for growth initiatives.

• Help ensure operational readiness for new therapeutic areas, protocols, and study types.

Key Internal Partnerships

This position will work closely with:

• President / CEO

• Medical Director

• Regulatory & Compliance Teams

• Study Start-Up Team

• Patient Recruitment Leadership

• Finance

• Site Managers

• Clinical Research Staff

Qualifications

• Bachelor's degree in Life Sciences, Healthcare Administration, or a related field .

• 8+ years of clinical research experience , preferably with significant experience in clinical research site operations.

• 3-5 years of leadership or management experience in clinical research or healthcare operations.

• Strong understanding of ICH-GCP, FDA regulations, clinical trial operations, and site-level processes .

• Experience working within a multi-site clinical research environment preferred.

• Demonstrated ability to manage operational performance, KPIs, and process improvement initiatives.

• Strong leadership, organizational, problem-solving, and communication skills.

• Ability to work collaboratively with clinical, regulatory, recruitment, and executive leadership teams.

Preferred Qualifications

• Experience with CNS clinical trials .

• Experience in behavioral health research .

• Experience managing or supporting operations across multiple clinical research sites.

• Experience with clinical research performance dashboards, metrics, and operational reporting.

Travel

• Regular travel between clinical research locations within South Florida and other national sites.

• Occasional travel for sponsor meetings, conferences, site expansion activities, and other business needs.

• The position requires a willingness to travel regularly to support site operations and performance.

\nCompany Description

Protouch Staffing is a trusted staffing partner specializing in connecting skilled professionals with top employers. While we originally focused on healthcare staffing, we’ve expanded into legal and other domains to meet evolving workforce needs across industries.

Company Description

Protouch Staffing is a trusted staffing partner specializing in connecting skilled professionals with top employers. While we originally focused on healthcare staffing, we’ve expanded into legal and other domains to meet evolving workforce needs across industries.