KUR Research · 1 day ago
Site Manager
KUR Research is a clinical research organization seeking a Site Manager to lead and oversee clinical trials. The role involves supervising research staff, ensuring compliance with FDA regulations, and managing operational and financial aspects of clinical studies.
Responsibilities
Supervise and mentor clinical research staff, including investigators, coordinators, and laboratory personnel
Organize, prioritize, and schedule work assignments to ensure optimal study execution
Provide direction and support during subject screening and enrollment to achieve study targets
Recruit, onboard, train, and evaluate team members, including conducting interviews and performance reviews
Promote a positive, compliant, and collaborative workplace culture aligned with organizational values
Oversee the conduct of all clinical trials in accordance with FDA regulations, ICH-GCP, and organizational SOPs
Ensure all personnel are trained on study protocols and assigned responsibilities prior to study activation
Monitor enrollment, retention, protocol adherence, and data quality
Implement corrective actions to address risks to timelines, enrollment, or study quality
Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs)
Maintain complete and compliant drug and device accountability records
Oversee IRB submissions, amendments, continuing reviews, and regulatory documentation
Manage vendor compliance and regulatory readiness for audits and inspections
Implement, monitor, and report on key performance indicators (KPIs) related to enrollment, quality, and timelines
Ensure accurate and timely completion of case report forms and EDC entries
Lead regular staff meetings and operational reviews
Serve as the primary liaison with Sponsors, CROs, and other external stakeholders
Understand and manage clinical trial budgets and site financial performance
Track visit completion, invoicing, and sponsor payments
Optimize site operations to support revenue growth, efficiency, and study profitability
Maintain operational and regulatory records
Provide coaching, feedback, and professional development to staff
Travel to investigator meetings, sponsor trainings, and site visits as required
Step in to support study coordination or laboratory functions during high-volume or staffing gaps
Qualification
Required
Minimum of five (5) years of experience in clinical research
Demonstrated experience in site operations or clinical trial management
Bachelor's degree in a related field
CITI training (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within the first two weeks of hire
Strong leadership, communication, and organizational skills
Ability to manage multiple studies, shifting priorities, and diverse therapeutic areas
High attention to detail and regulatory compliance
Ability to travel locally and nationally as required
Must be based on-site at an assigned clinical research location
Willingness to work flexible hours and assume additional responsibilities as needed
Experience with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS)
Proficiency with Microsoft Teams, PDF editing tools, and DocuSign
Ability to lift, carry, push, or pull up to 10 pounds
Ability to sit, stand, walk, bend, and move throughout the workday
Adequate coordination and dexterity to handle equipment and assist patients safely
Preferred
Seven (7) to ten (10) years of experience in clinical research
Master's degree
CRC certification