Clinical Site Director

Position Summary

The Clinical Site Director is responsible for the overall operational leadership and performance of a clinical research site. This role oversees day-to-day site operations, staff management, study execution, regulatory compliance, and performance metrics to ensure the successful delivery of clinical trials.

The Clinical Site Director partners with internal departments, investigators, sponsors, and site personnel to drive enrollment, maintain quality standards, ensure participant safety, and achieve study milestones while adhering to ICH-GCP, FDA regulations, and company policies.

Key Responsibilities

Site Operations & Performance Management

• Provide overall leadership and management of clinical research site operations with a focus on operational excellence, participant safety, regulatory compliance, and study performance.
• Monitor key performance indicators and operational metrics to drive efficiency, identify areas for improvement, and ensure achievement of site goals.
• Oversee clinical trial activities to ensure studies are conducted according to protocol requirements, sponsor expectations, and regulatory standards.
• Review site performance dashboards and reporting tools to monitor study progress, staffing coverage, participant activity, and operational execution.
• Ensure timely and accurate completion of study-related activities, including participant visits, follow-up communications, and data collection requirements.
• Identify operational risks and implement proactive solutions to maintain study timelines, quality standards, and budget expectations.

Cross-Functional Collaboration

• Partner with Business Development, Patient Recruitment, Finance, Contracts, Budgets, and Quality teams to support study start-up, enrollment goals, and sponsor deliverables.
• Collaborate with investigators and study teams to ensure participant safety, protocol compliance, and successful study outcomes.
• Support strategic planning efforts to meet enrollment targets, site activation goals, and operational milestones.
• Participate in management meetings and provide updates on site performance, challenges, and improvement initiatives.

Staff Leadership & Development

• Direct and oversee site personnel, ensuring appropriate staffing levels and resource allocation across studies.
• Manage employee lifecycle activities, including recruiting, interviewing, onboarding, training, performance evaluations, coaching, and employee relations.
• Monitor staff productivity and performance to ensure study deliverables are met efficiently and effectively.
• Foster a collaborative, high-performing team culture focused on quality, accountability, and continuous improvement.
• Oversee payroll administration, attendance tracking, scheduling, and training programs to support operational needs.

Quality & Compliance

• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, HIPAA requirements, and organizational policies.
• Provide oversight of protocol-specific training, study procedures, case report form (CRF) completion, and standard operating procedures (SOPs).
• Conduct ongoing assessments of staff training, study processes, and compliance standards to identify potential risks and gaps.
• Develop, implement, and monitor corrective and preventive action plans (CAPAs) when necessary.
• Maintain a strong focus on data integrity, participant safety, and quality throughout all study activities.

Additional Responsibilities

• Apply strategic thinking and problem-solving skills to address operational challenges and optimize site performance.
• Support continuous process improvement initiatives and operational best practices.
• Perform additional duties and special projects as assigned.

Qualifications

Education & Experience

• Bachelor's degree required; equivalent combinations of education and relevant experience may be considered.
• Minimum of five (5) years of clinical research experience.
• Minimum of two (2) years of leadership or management experience.
• Prior clinical research site management experience strongly preferred.
• Bilingual proficiency in English and Spanish is a plus.

Required Skills & Competencies

• Strong knowledge of clinical research operations, FDA regulations, ICH-GCP guidelines, and HIPAA requirements.
• Proficiency with Microsoft Office applications, electronic health record systems, web-based platforms, and other clinical research technologies.
• Excellent organizational, project management, and time management skills with the ability to manage competing priorities.
• Strong analytical and problem-solving abilities with a focus on operational efficiency and continuous improvement.
• Exceptional written, verbal, and interpersonal communication skills.
• Ability to build effective working relationships with investigators, sponsors, participants, and cross-functional teams.
• Demonstrated leadership capabilities with experience coaching, mentoring, and developing staff.
• Ability to work independently, exercise sound judgment, and make informed decisions in a fast-paced environment.
• High level of professionalism, integrity, accountability, and confidentiality.
• Ability to manage sensitive information in accordance with HIPAA and organizational privacy standards.
• Strong attention to detail and commitment to delivering high-quality results.

  Clinical Site Director

  Position Summary

  The Clinical Site Director is responsible for the overall operational leadership and performance of a clinical research site. This role oversees day-to-day site operations, staff management, study execution, regulatory compliance, and performance metrics to ensure the successful delivery of clinical trials.

  The Clinical Site Director partners with internal departments, investigators, sponsors, and site personnel to drive enrollment, maintain quality standards, ensure participant safety, and achieve study milestones while adhering to ICH-GCP, FDA regulations, and company policies.

  Key Responsibilities

  Site Operations & Performance Management

• Provide overall leadership and management of clinical research site operations with a focus on operational excellence, participant safety, regulatory compliance, and study performance.
• Monitor key performance indicators and operational metrics to drive efficiency, identify areas for improvement, and ensure achievement of site goals.
• Oversee clinical trial activities to ensure studies are conducted according to protocol requirements, sponsor expectations, and regulatory standards.
• Review site performance dashboards and reporting tools to monitor study progress, staffing coverage, participant activity, and operational execution.
• Ensure timely and accurate completion of study-related activities, including participant visits, follow-up communications, and data collection requirements.
• Identify operational risks and implement proactive solutions to maintain study timelines, quality standards, and budget expectations.

• Cross-Functional Collaboration

• Partner with Business Development, Patient Recruitment, Finance, Contracts, Budgets, and Quality teams to support study start-up, enrollment goals, and sponsor deliverables.
• Collaborate with investigators and study teams to ensure participant safety, protocol compliance, and successful study outcomes.
• Support strategic planning efforts to meet enrollment targets, site activation goals, and operational milestones.
• Participate in management meetings and provide updates on site performance, challenges, and improvement initiatives.

• Staff Leadership & Development

• Direct and oversee site personnel, ensuring appropriate staffing levels and resource allocation across studies.
• Manage employee lifecycle activities, including recruiting, interviewing, onboarding, training, performance evaluations, coaching, and employee relations.
• Monitor staff productivity and performance to ensure study deliverables are met efficiently and effectively.
• Foster a collaborative, high-performing team culture focused on quality, accountability, and continuous improvement.
• Oversee payroll administration, attendance tracking, scheduling, and training programs to support operational needs.

• Quality & Compliance

• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, HIPAA requirements, and organizational policies.
• Provide oversight of protocol-specific training, study procedures, case report form (CRF) completion, and standard operating procedures (SOPs).
• Conduct ongoing assessments of staff training, study processes, and compliance standards to identify potential risks and gaps.
• Develop, implement, and monitor corrective and preventive action plans (CAPAs) when necessary.
• Maintain a strong focus on data integrity, participant safety, and quality throughout all study activities.

• Additional Responsibilities

• Apply strategic thinking and problem-solving skills to address operational challenges and optimize site performance.
• Support continuous process improvement initiatives and operational best practices.
• Perform additional duties and special projects as assigned.

• Qualifications

  Education & Experience

• Bachelor's degree required; equivalent combinations of education and relevant experience may be considered.
• Minimum of five (5) years of clinical research experience.
• Minimum of two (2) years of leadership or management experience.
• Prior clinical research site management experience strongly preferred.
• Bilingual proficiency in English and Spanish is a plus.

• Required Skills & Competencies

• Strong knowledge of clinical research operations, FDA regulations, ICH-GCP guidelines, and HIPAA requirements.
• Proficiency with Microsoft Office applications, electronic health record systems, web-based platforms, and other clinical research technologies.
• Excellent organizational, project management, and time management skills with the ability to manage competing priorities.
• Strong analytical and problem-solving abilities with a focus on operational efficiency and continuous improvement.
• Exceptional written, verbal, and interpersonal communication skills.
• Ability to build effective working relationships with investigators, sponsors, participants, and cross-functional teams.
• Demonstrated leadership capabilities with experience coaching, mentoring, and developing staff.
• Ability to work independently, exercise sound judgment, and make informed decisions in a fast-paced environment.
• High level of professionalism, integrity, accountability, and confidentiality.
• Ability to manage sensitive information in accordance with HIPAA and organizational privacy standards.
• Strong attention to detail and commitment to delivering high-quality results.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

^*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.