Head of Clinical Research Operations - 250803

Job title: Head of Clinical Research Operations (HCRO)

Location: Mesquite, TX (Relocation candidates will be considered; Texas-based candidates preferred)

A growing, physician-led clinical research site in the Dallas–Fort Worth area is conducting a confidential search for an experienced Head of Clinical Research Operations to lead operations at a high-performing, single-site research organization.

This is a pivotal leadership opportunity for a seasoned research professional who is ready to step into a true operational leadership role — partnering directly with the Principal Investigator (PI) to drive site performance, sponsor relationships, and long-term expansion strategy.

About the Opportunity

The HRCO works as the primary advisor to the organization's senior management on matters related to research administrative tasks. This role includes facilitation and leads implementation of efficient strategies, compliance with quality standards and patient satisfaction, financial planning and execution, recruitment, performance evaluation and staff training, research marketing, outreach, building relationships with community physicians.

The site is led by an experienced and well-respected Principal Investigator who currently serves as the primary PI across multiple active trials. With a strong internal team already in place — including 12 CRCs, regulatory staff, laboratory personnel, and administrative support — the organization is seeking a strategic operational leader who can elevate execution, streamline processes, and serve as the external-facing representative to sponsors and CROs.

The current structure includes an acting site manager; however, this role is designed to establish a more strategic Head of Operations who can fully oversee study conduct, financial oversight, and business development initiatives, allowing the PI to focus on patient care and scientific leadership.

This is a family-operated organization with strong values, long-term vision, and plans for future satellite site expansion.

Key Responsibilities

• Direct interaction with clinic operations, working in collaboration with other leadership to, achieve targets.
• Monitors, trends and provides action plans for Key Performance Indicators (KPIs) within the Research services operations.
• Hire, develop, and motivate research employees to achieve objectives
• Ensure regulatory compliance with guidelines, rules and laws that govern clinical research
• Plan and supervise the recruitment plans of enrolling clinical trials
• Have a deep understanding of all protocols and be available as a resource for all site staff.
• Review e-source made by site staff for completeness and accuracy
• Coordinate and oversee Investigators and Clinical Research staff trainings and meetings
• Assist CFO as needed for clinical research program business operations including finance, budget, and accounts payable/receivable
• Achieve financial growth goals and quality measures
• Forecast growth and other success factors as established by senior leadership.
• Set budgets and enrollment forecasts for sites
• Identify areas for streamlining delivery of and billing for Research
• Act as primary point of contact for new trial leads, overseeing feasibility assessments and negotiation of budgets and contracts.
• Liaison with the research community for new growth initiatives and industry sponsor relationships in an effort to increase the research service line
• Draft and execute business plans that meet corporate objectives in targeted accounts through needs assessment and the development and implementation of strategies that achieve mutually agreed upon goals, including both a short-term/opportunity focus, as well as a longer-term focus on the mutual benefits shaping Research services
• Consistent with needs assessment and mutual goals, develop and execute regional strategies to accelerate growth, garner account loyalty through resource deployment and collaboration with physicians, internal operations management, executive leadership, training and marketing.
• Anticipate and proactively manage business disruptions from adverse events such as shipping impacts from adverse weather, carrier disruptions, system outages, etc.
• Cultivate internal provider relationships to foster implementation of research studies.
• Effectively lead the design and organization of work and allocation of resources to achieve the appropriate staffing levels.
• Demonstrate knowledge of regulatory bodies requirements, inspections, and audits.
• Ensure that programs are in place as prescribed by regulatory bodies to ensure compliant operations.
• Adheres to all safety policies and procedures in performing job duties and responsibilities while supporting a culture of high quality and great customer service.
• Performs other duties that may be necessary or in the best interest of the organization.

Ideal Candidate Profile

• 7+ years of clinical research experience with progressive operational leadership
• Prior experience as a Site Director, Senior Clinical Research Manager, or equivalent
• Strong understanding of study budgets, contracts, and sponsor negotiations
• Experience running multiple concurrent trials
• Demonstrated ability to lead and scale teams
• Strong sponsor-facing presence and communication skills
• Entrepreneurial mindset with interest in long-term growth
• Willingness to relocate to the Dallas–Fort Worth area (if not local)

OTHER SKILLS/ABILITIES:

• Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
• Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
• Strong written and verbal communication skills
• An ability to consume, absorb, and analyze large amounts of information.
• Ability to multitask, work under time constraints, work independently and cooperatively with interdisciplinary teams.
• Strong computer skills in appropriate software and related company clinical systems is required

Candidates who bring both hands-on study leadership experience and a strategic mindset will thrive in this environment.

Why This Role?

• Direct partnership with an experienced, respected PI
• Established infrastructure and strong study pipeline
• Opportunity to build and formalize operational leadership
• Strategic input into site expansion and growth
• Competitive compensation structure
• Long-term leadership track within a growing organization