Clinical Research Site Manager

Unclassified - The Woodlands, TX

Full-time - Mid Level

The Woodlands, TX

About the position

We are seeking a highly motivated and experienced Clinical Research Site Manager to oversee the daily operations of multiple clinical trials and manage a team of research staff. The ideal candidate will have a robust background as a Clinical Research Coordinator combined with proven exceptional leadership experience, a keen understanding of regulatory compliance, a strong drive to advance our research initiatives, and preparation to take on the challenges of managing complex research projects in a private practice setting (specific to a Rheumatology clinic). This role is critical in ensuring our trials are conducted with the highest standards, as well as in taking our research to the next level of excellence. The Clinical Research Site Manager will manage the execution of multiple clinical trials, ensuring that all activities are conducted in compliance with study protocols, regulatory requirements, and ethical standards. This includes developing and managing budgets for studies, handling invoicing and payments related to the study, and leading, mentoring, and motivating a team of research coordinators and support staff. The manager will also provide guidance, train and support other research staff and new team members on trial protocols and procedures, and foster a culture of excellence and continuous improvement within the team. Additionally, the role requires maintaining up-to-date knowledge of regulatory changes, ensuring all required documentation is accurate and complete, and coordinating the administrative aspects of clinical trials, including scheduling, budgeting, agreements, and resource management. The Clinical Research Site Manager will serve as the primary contact for trial participants, ensuring they are fully informed about the study and addressing any questions or concerns they may have throughout the study. This position is essential for ensuring data integrity, accuracy, and confidentiality, as well as preparing for and managing audits and inspections by regulatory bodies.

Responsibilities

• Manage the execution of multiple clinical trials, ensuring compliance with study protocols, regulatory requirements, and ethical standards.
• Develop and manage budgets for studies, including managing expenses and ensuring financial compliance.
• Handle invoicing and payments related to the study.
• Lead, mentor, and motivate a team of research coordinators and support staff.
• Provide guidance and training to research staff and new team members on trial protocols and procedures.
• Foster a culture of excellence and continuous improvement within the team.
• Ensure adherence to regulatory guidelines and institutional policies.
• Maintain up-to-date knowledge of regulatory changes and ensure all required documentation is accurate and complete.
• Ensure studies are approved by the relevant ethics committees or institutional review boards (IRBs).
• Review new protocols, prepare feasibility reports, and attend site selection and site initiation visits.
• Prepare and submit regulatory documents, including Institutional Review Board (IRB) submissions and updates.
• Maintain accurate and up-to-date regulatory files.
• Coordinate the administrative aspects of clinical trials, including scheduling, budgeting, agreements, and resource management.
• Implement processes to enhance operational efficiency.
• Serve as the primary contact for trial participants, ensuring they are fully informed about the study and obtain their consent before participation.
• Oversee the recruitment of study participants, ensuring that inclusion and exclusion criteria are met.
• Collect, record, and manage study data in accordance with protocol requirements.
• Ensure data integrity, accuracy, and confidentiality.
• Maintain detailed and accurate study documentation, including source documents, case report forms, and adverse event reports.
• Prepare for and manage audits and inspections by regulatory bodies, ensuring compliance with regulations.
• Coordinate with investigators, study sponsors, and other stakeholders to ensure smooth trial execution.
• Prepare and present reports on trial progress, including updates to Investigators and regulatory bodies.
• Address any issues or deviations promptly and effectively.

Requirements

• Bachelor's degree in a related field (e.g., Nursing, Life Sciences, Public Health). An advanced degree or certification is a plus.
• Minimum of 5 years of experience in clinical research, with at least 2 years in a leadership or management role.
• Minimum of 3 years of experience as a Clinical Research Coordinator or in a similar role.
• Competent leadership and team management skills.
• Strong organizational and time-management skills with the ability to manage multiple tasks and priorities.
• Effective communication and interpersonal skills, with the ability to interact professionally with patients, research staff, sponsors, etc.
• Excellent knowledge of clinical research regulations (e.g., FDA, GCP/ICH guidelines) and ethics committee requirements.
• Comprehensive understanding of clinical research processes and regulatory requirements.
• Meticulous attention to detail to ensure accuracy in data collection and a commitment to maintaining data integrity and compliance with regulations.
• Proven proficiency in data management systems.
• Demonstrated ability to innovate and drive research initiatives forward.
• Proficiency in Spanish is a plus.

Nice-to-haves

• Proficiency in Spanish is a plus.

Benefits

• Compensation to correspond with degree and experience.