Overview

At Headlands Research, we are building a best in class clinical trial network. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement Founded in 2018, our company operates 18 clinical trial sites in the US and Canada with rapid plans for expansion.

This is a full-time position located at our site in Atlantis, FL (Lake Worth).

You can read more about us at www.headlandsresearch.com

The Role

Reporting to the Senior Director of Regional Operations, the Site Director’s role is to implement and support operational processes and systems to ensure patient and sponsor satisfaction, quality of data, efficiency of site operations, highest level of employee engagement and performance, and adherence to regulations and protocol. In addition to managing site day-to-day operations, the Director coaches, and mentors all site employees, so that each can reach their highest potential and contribute to a strong performing team.

Responsibilities

• Manage site facilities and workflow to ensure that patients/subjects, staff, and sponsors have the best customer service experience
• Oversight of study management including timely review of monitor reports and associated study deliverables
• Create risk management plans and mitigation strategies as part of study-start up management
• Staff management and proactive assessment of staffing needs to include hiring, training, and coaching/mentoring staff with monthly one to one meetings
• Responsible for site and study audits and inspections as needed
• Identify, assess, and work to resolve site performance and quality/compliance issues
• Perform and lead sponsor/CRO site visits, including but not limited to, site selection site initiation, quality visits, and perform close out visits as needed
• Ensure site meets monthly screening, randomization, and completion/retention goals by assessing scheduling, troubleshooting, and maximizing staff availability
• Follow a quality process as outlined in the Site's SOP's to ensure the site collects and enters high quality data and to reduce preventable deviations 
• Coordinate and manage various tasks in collaboration with the Quality team to achieve site readiness for timely first patient first visit
• Obtain and maintain in-depth understanding of the study protocols and related procedures in order to contribute to the study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as needed/required
• Responsible for external vendor management to include onboarding of site partners, oversight, and training
• Ensure the site has high morale and works well as a team and meets our cultural goals and expectations

• Oversee financial and contractual performance on studies
• Maintain strong relationship and work as liaison between clinical team and Sponsor/Contract Research Organization (CRO)
• Perform other duties as assigned

Qualifications

Education:

• Bachelor’s degree

Experience:

• Clinical Trials: 1-3 years (Required)
• People Management: 1-3 years (Required)
• 3 years of experience in clinical trials as a primary study coordinator, data structuring, or project coordination preferred
• P&L experience a plus

Skills:

• Healthcare or research experience preferred, clinical management a plus
• Demonstrated experience motivating and inspiring teams; train and develop staff
• Strong critical thinking and proactive problem solving
• Ability to multitask and attention to detail, while leading planning and organizing for the site
• Intermediate/comfortable with computer skills
• Ability to communicate clearly and effectively to all levels of the organization (written and oral)
• Excellent interpersonal and customer service skills