Clinical Research Site Manager

Job Summary
We are seeking a dynamic and highly organized Clinical Research Site Manager to lead and oversee the daily operations of our clinical trial site. In this pivotal role, you will coordinate all aspects of clinical trials, ensuring compliance with regulatory standards, maintaining high-quality documentation, and fostering a patient-centered environment. Your leadership will drive the successful execution of research studies, facilitate effective communication among team members, and uphold the integrity of data collection and management. This position offers an exciting opportunity to contribute to groundbreaking medical research while supporting the advancement of healthcare solutions.

Responsibilities

• Supervise and coordinate the activities of clinical research staff, including nurses, coordinators, and laboratory personnel, ensuring seamless trial operations
• Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure adherence to study protocols and regulatory requirements
• Oversee data collection processes, review source documents for accuracy, and ensure proper documentation in accordance with ICH GCP standards and FDA regulations
• Maintain compliance with HIPAA regulations and ensure confidentiality of patient information throughout all trial activities
• Review clinical documentation such as case report forms (CRFs), laboratory results, vital signs, and adverse event reports for completeness and accuracy
• Monitor clinical laboratory procedures including blood sampling, phlebotomy, and specimen handling to ensure quality standards are met
• Utilize electronic medical record (EMR) systems and statistical software for data management, analysis, and reporting purposes
• Ensure adherence to CDISC standards for data formatting and reporting in clinical trials
• Conduct regular site audits to verify compliance with protocol requirements and regulatory guidelines
• Facilitate training sessions on Good Clinical Practice (GCP), FDA regulations, and study-specific procedures for staff members

Qualifications

• Proven supervising experience in a clinical research environment or healthcare setting
• Strong knowledge of clinical trials management, including patient monitoring and data collection techniques
• Familiarity with medical terminology, clinical laboratory procedures, and blood sampling techniques
• Experience with EMR systems, statistical software, and data management tools used in clinical research
• In-depth understanding of FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards
• Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; additional certifications such as an ICH GCP certificate are preferred
• Background in nursing or clinical laboratory work is advantageous
• Excellent analysis skills with attention to detail for reviewing documentation and ensuring protocol adherence
• Ability to lead teams effectively while maintaining a positive work environment

Join us in advancing innovative healthcare solutions by managing impactful clinical research studies. Your expertise will help shape the future of medicine while supporting a collaborative team dedicated to excellence in clinical development.

Pay: $20.00 - $38.00 per hour

Benefits:

• 401(k)
• Health insurance
• Paid time off

Work Location: In person