Job Description

Job Summary:
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.

Qualifications:

Education:

• Bachelor’s degree in a related field (e.g., Nursing, Life Sciences, Public Health). An advanced degree or certification is a plus.

Experience:

• Minimum of 5 years of experience in clinical research, with at least 2 years in a leadership or management role and a minimum of 3 years of experience as a Clinical Research Coordinator or in a similar role.

Skills:

• 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, as well as 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.

Key Responsibilities:

• Manage the execution of multiple clinical trials, ensuring that all activities are conducted in 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. Train and support other 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 that studies are approved by the relevant ethics committees or institutional review boards (IRBs).
• Review new protocols, prepare feasibility reports, 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. Ensure that participants are fully informed about the study and obtain their consent before participation and address any questions or concerns participants may have throughout the study.
• Oversee the recruitment of study participants, ensuring that inclusion and exclusion criteria are met. Follow-up with participants as needed.
• Can step in to perform clinical trial duties as required.
• 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.
• Ensure that all research activities comply with federal, state, and institutional regulations. Maintain accurate and up-to-date documentation.
• Facilitate effective communication with trial participants, ensuring they are well-informed and comfortable throughout the research process.
• Prepare for and manage audits and inspections by regulatory bodies, ensuring that all aspects of the study are compliant with regulations.
• Coordinate with investigators, study sponsors, and other stakeholders to ensure smooth trial execution. Communicate effectively with all team members and ensure timely resolution of any issues.
• Prepare and present reports on trial progress, including updates to Investigators and regulatory bodies.
• Prepares and presents monthly and annual status reports to site investigator
• Address any issues or deviations promptly and effectively.
• May be required to attend occasional off-site meetings and Investigator meetings.
• Identify opportunities to enhance and expand research capabilities.
• Must life within 30 min drive to The Woodlands, TX.

Compensation to correspond with degree and experience.

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