Clinical Research Site Director

About Us

We are a leading clinical research site network. Our network is known for recruiting and retaining highly diverse patient populations across key therapeutic areas such as cardiology, metabolic disorders, CNS, pulmonology, and vaccines. With a robust infrastructure and cutting-edge technology, we ensure superior patient engagement and high-quality data delivery. Our commitment to excellence is supported by a focus on quality management systems, patient diversity, and clinical expertise.

The Role & Opportunity

The Site Director in Miami, FL (Little Gables) will oversee all operational functions of the clinic, including financial performance, team leadership, and operational efficiency. Reporting to the Regional Director of Operations, this role ensures the delivery of high-quality clinical trials and aligns with our mission to provide exceptional service to clients and patients alike.

Responsibilities

Financial & Operational Oversight:

• Lead operational and clinical initiatives to meet company goals and ensure site success.

• Manage site-level financial metrics, including budgets, revenue targets, and continuous improvement strategies.

• Gain a comprehensive understanding of the site's operations, market position, and competitive advantages.

• Optimize staffing levels based on operational demands and workload analysis.

• Mentor and guide clinical and administrative staff to execute strategies effectively.

• Drive team performance and provide ongoing coaching and development.

• Oversee the site\u2019s P&L, meeting or exceeding EBITDA and other key financial targets.

• Implement processes to sustain profitability and operational productivity.

• Manage both fixed and variable costs while planning capital expenditures as needed.

• Utilize clinical trial agreements and budgets to maximize revenue opportunities.

• Monitor and act upon key performance indicators.

Team Leadership:

• Recruit, train, and develop clinical and administrative team members to achieve performance objectives.

• Conduct regular performance assessments and provide recognition and coaching for growth.

• Identify and address training needs for site-level management and team members.

• Champion organizational culture and engagement initiatives, working collaboratively with leadership teams.

• Collaborate with training departments to design and implement development programs for staff.

• Develop recruitment strategies to support site and market growth.

• Share best practices and collaborate with other Site Directors to address challenges.

Operational & Clinical Management:

• Provide backup support to various departments, including clinical research coordination, pharmacy, lab, and data entry.

• Train and supervise staff on clinical trial procedures such as consenting patients, taking vitals, and performing ECGs.

• Work with quality and risk management teams to ensure compliance with regulations and protocols.

• Represent the site during sponsor visits, including pre-study, monitoring, and close-out visits.

• Maintain compliance with regulatory guidelines and ensure patient safety through appropriate staff training.

• Foster ongoing collaboration with investigators to maintain compliance and quality in clinical studies.

• Collaborate with quality control teams to ensure timely and accurate data submission.

• Partner with centralized support teams to meet service-level targets, including HR, feasibility, budgets, and IT.

• Develop and manage patient recruitment programs to meet clinical trial enrollment goals.

Minimum Qualifications:

• Bilingual proficiency in spoken and written Spanish is required.

• Bachelor's degree in a relevant field such as science, nursing, or healthcare management.

• At least 5 years of experience working on industry-sponsored clinical trials, with exposure to pharmaceutical frameworks.

• A minimum of 2 years of leadership experience managing direct reports, preferably at the site level.

• Experience supporting key sponsors and CROs.

• Proficiency in managing complex therapeutic areas and study designs.

• Strong ability to mentor and guide all levels of Clinical Research Coordinators (CRCs) to ensure understanding of clinical research processes, SOPs, and values, fostering growth into more advanced responsibilities.

• Experience assisting regional leadership in quality control checks for study documentation.

• Demonstrated deep knowledge of specific therapeutic areas and protocol designs.

• Continuous independent learning in therapeutic areas of responsibility.

• Experience acting as a primary point of contact within a therapeutic field for stakeholders.

• Strong leadership and team-building skills.

• Proficiency in Word, Excel, and PowerPoint.

• Exceptional project management, problem-solving, and multitasking abilities.

• Entrepreneurial mindset with the ability to work independently.

• Strong planning and execution skills to operationalize strategies effectively.

• Willingness to travel and work occasional nights and weekends as required by business needs.

Professional Skills

• Expertise in forecasting and business planning from operational and financial perspectives.

• Ability to manage multiple priorities in a dynamic environment.

• Independent problem-solving skills with a focus on delivering solutions in a fast-paced setting.

• Experience in developing and implementing operational improvements.

• Skilled in negotiation, conflict resolution, and team collaboration.

• Strong communication skills, both oral and written.

• Familiarity with Office365 and other relevant applications.

• Experience in creating and adhering to Standard Operating Procedures (SOPs).

• Proven ability to assess risks and implement effective solutions.

• Track record of success in process improvement and team management initiatives.

• Proficient in training and conducting basic clinical procedures such as blood draws, ECGs, and vital signs.

• Ability to review and ensure accuracy of laboratory and clinical test results, ensuring timely investigator review.

• Competent in identifying and escalating adverse events (AEs) and Serious Adverse Events (SAEs) promptly to investigators and sponsors.

• Strong interpersonal skills for maintaining effective relationships with patients, sponsors, investigators, and colleagues.

Minimum Qualifications

• Proficiency in conversational Spanish is required; fluency in both verbal and written Spanish is strongly preferred.

• A bachelor’s degree in a relevant field such as life sciences, healthcare management, or nursing.

• At least 5 years of clinical research experience, specifically with industry-sponsored trials. Experience in institutional settings, such as hospitals or academic centers, will also be considered if it includes work on pharmaceutical-sponsored evaluations of new drugs, biologics, vaccines, or medical devices.

• A minimum of 2 years of experience overseeing direct reports, with a preference for candidates who have managed site-level leaders.

• Prior experience in cardiometabolic therapeutic areas is advantageous.

• Demonstrated ability to lead teams and foster a collaborative work environment.

• Proficiency in professional tools such as Microsoft Word, Excel, and PowerPoint.

• Strong skills in project management, problem-solving, and managing multiple priorities in dynamic settings.

• A self-starter with an independent work ethic and entrepreneurial mindset.

• Proven expertise in planning and executing strategies to achieve operational goals.

• The role requires the ability to work onsite near the Brickell and Little Gables areas of Miami, Florida. Relocation assistance may be available.

• Travel within Florida, approximately 10%, may be required based on business needs.