What are the responsibilities and job description for the Clinical Research Site Director position at Medix?
Location : Amarillo, TX
Type : Full-Time and On-Site
Position Overview :
The Site Director is responsible for leading clinical research operations at the assigned research center. This includes managing clinical trial activities, overseeing patient care, ensuring regulatory compliance, and driving site performance to meet organizational goals. The role involves both strategic oversight and hands-on responsibilities to ensure successful study execution and a positive patient experience.
Key Responsibilities
Clinical Trial Management
Oversee all clinical research activities, ensuring compliance with IRB-approved protocols, Good Clinical Practices (GCPs), and regulatory standards.
Direct patient recruitment, screening, enrollment, and data collection to meet study goals.
Supervise study start-up, monitoring, and close-out processes in collaboration with sponsors and study teams.
Maintain accurate and timely entry of study data in electronic data capture (EDC) systems.
Patient Care and Research Activities
Administer patient consent, conduct physical assessments, and perform clinical procedures, including venipuncture, ECGs, and medication administration.
Ensure proper handling of biological specimens and investigational products.
Track and report adverse events (AEs) and serious adverse events (SAEs) according to sponsor and regulatory requirements.
Operational Oversight
Manage day-to-day site operations, including staffing, scheduling, and quality control.
Act as the primary liaison between investigators, sponsors, and stakeholders, maintaining clear communication and coordination.
Monitor and ensure achievement of site performance goals, including patient visit metrics and study milestones.
Leadership and Team Development
Supervise, train, and mentor site staff, fostering professional growth and adherence to company standards.
Conduct performance reviews and provide ongoing feedback to team members.
Promote a collaborative and supportive team environment while upholding organizational values.
Regulatory and Quality Assurance
Maintain up-to-date regulatory documentation and source documents for all studies.
Ensure HIPAA compliance and adherence to ethical research practices.
Participate in internal and external audits, implementing corrective actions as needed.
Qualifications
Required
High school diploma or equivalent.
At least two years of experience in clinical research.
Strong leadership and organizational skills with experience in IRB submissions.
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