Site Manager Global Clinical Research Organization

Site Manager Global Clinical Research Organization SF Research Institute Inc. San Francisco, CA Job Details Full-time $89,898.95 - $108,265.40 a year 8 hours ago Qualifications Clinical research Achieving HIPAA compliance Maintaining patient confidentiality HIPAA Laboratory experience Research ICH guidelines CDISC standards Data entry Research regulatory compliance FDA regulations Full Job Description Job Summary We are seeking a dynamic and experienced Site Manager to lead our Global Clinical Research Organization (CRO) operations. In this pivotal role, you will oversee the planning, execution, and management of clinical trials across multiple sites, ensuring compliance with regulatory standards and delivering high-quality data. Your leadership will drive the success of clinical development projects by coordinating multidisciplinary teams, maintaining rigorous documentation, and fostering a culture of excellence. This position offers an exciting opportunity to influence groundbreaking medical research while ensuring operational efficiency and regulatory adherence on a global scale. Responsibilities Lead and supervise clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Oversee patient recruitment, screening, enrollment, and monitoring activities to ensure accurate and timely data collection. Manage site staff including clinical research coordinators, nurses, phlebotomists, and other healthcare professionals; provide mentorship and performance feedback. Review and approve study documentation such as case report forms (CRFs), informed consent forms (ICFs), and source documents for accuracy and completeness. Ensure compliance with FDA regulations, ICH GCP standards, HIPAA privacy rules, and CDISC data standards throughout all trial activities. Coordinate with laboratories for blood sampling, clinical laboratory testing, and analysis while maintaining proper documentation of vital signs and other clinical data. Utilize electronic medical record (EMR) systems for data entry, management, and reporting; ensure data integrity and confidentiality at all times. Monitor site performance metrics; implement corrective actions when necessary to meet project timelines and quality benchmarks. Facilitate communication between sponsors, regulatory bodies, investigators, and site teams to ensure smooth trial progression. Conduct regular site visits to review compliance procedures, conduct audits, and address any issues promptly. Qualifications Proven supervising experience in clinical research or related healthcare settings with a strong understanding of clinical trials management. Knowledge of medical terminology, blood sampling techniques, patient monitoring procedures, and clinical laboratory processes. Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance standards, and CDISC data standards is essential. Experience working with EMR systems and statistical software used in clinical research environments. Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; ICH GCP certification is highly preferred. Background in nursing or clinical laboratory work is advantageous; relevant experience in blood sampling or phlebotomy is a plus. Strong analysis skills with the ability to review complex documentation critically while maintaining meticulous attention to detail. Excellent leadership capabilities with supervisory experience managing multidisciplinary teams across multiple sites. Ability to navigate regulatory environments effectively while fostering a culture of compliance management within the team. Join us to lead innovative clinical trials that make a real difference! We are committed to supporting your professional growth through comprehensive training programs while providing an inclusive environment that values your expertise in advancing global health initiatives.

Pay:

$89,898.95 - $108,265.40 per year

Work Location:

In person