Site Manager

How This Role Makes a Difference

The Site Manager is responsible for the day-to-day operational leadership of the Lake Charles research site. This role directly manages site staff and is accountable for study execution, documentation quality, regulatory compliance, and team performance. The Site Manager remains hands-on in the conduct of complex clinical trials while ensuring the broader team delivers consistently high standards of protocol adherence and patient care. This role partners closely with the Principal Investigator, who retains medical and regulatory authority for all clinical decisions.

How Youll Make an Impact

Team Leadership & Performance

• Directly manage and develop Clinical Research Coordinators, Phlebotomists, and Lab Technicians
• Set and uphold clear expectations for quality, compliance, timelines, and patient experience
• Provide ongoing coaching, performance feedback, and structured development
• Address performance issues promptly and build a high-accountability team culture

Study Execution & Operational Oversight

• Lead the site's most complex and high-priority studies
• Oversee protocol implementation, enrollment progress, visit execution, and data timeliness
• Identify operational risks and implement corrective actions to maintain study timelines
• Ensure continuous inspection readiness and successful monitoring visits
• Partner with the Principal Investigator on operational study conduct; all medical decisions remain under PI authority

Quality & Compliance

• Ensure strict adherence to FDA regulations, ICH-GCP, and Care Access SOPs
• Maintain high standards for source documentation, data integrity, and protocol compliance
• Proactively monitor and reduce protocol deviations
• Ensure timely escalation of safety events and compliance concerns

Sponsor & CRO Engagement

• Serve as the primary operational contact for sponsors and CROs
• Represent the site in start-up activities, monitoring visits, and escalation discussions
• Build strong sponsor relationships through consistent, reliable execution

Hands-On Clinical Contribution

• Conduct study visits and protocol-required procedures as needed
• Perform phlebotomy, ECGs, vital signs, and other clinical tasks
• Support informed consent processes and investigational product accountability
• Assist with additional projects such as report design, data maintenance, etc.

The Expertise Required

• Strong working knowledge of FDA regulations, ICH-GCP, and clinical research compliance requirements
• Demonstrated success managing complex clinical trials in a site-based environment
• Proven ability to lead, coach, and hold clinical research staff accountable for performance
• Experience overseeing protocol implementation, enrollment progress, and documentation quality
• Sound operational judgment with the ability to identify risks and drive corrective action
• Experience serving as a primary operational contact for sponsors or CROs
• Strong written and verbal communication skills
• Proficiency with EDC systems, clinical trial databases, and standard business software

Requirements

• Bachelor's degree preferred or equivalent combination of education and experience
• 5+ years of clinical research experience, including time as a Clinical Research Coordinator
• Prior direct people management experience required
• Demonstrated experience leading complex or high-volume studies
• Recent phlebotomy experience required

How We Work Together

Location and Travel

• This is an on-site position with regional commute requirements, located in Lake Charles, LA.
• Travel: This role requires up to 10% of regional (within 100 miles) travel requirements for Future of Medicine community screening events.

Physical Demands

• The ability to use keyboards and other computer equipment.
• Walking - 20%
• Standing - 20%
• Sitting - 50%
• Lifting (up to 25 lbs) - 10%

Compensation and Benefits

The expected salary range for this role is $75,000 - $95,000 USD per year for full-time team members.

Benefits & Perks (US Full Time Employees)

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match