Clinical Research Site Director

Description

Clinical Research Site Director - Oncology

A respected hematology and oncology research center in Los Angeles is seeking a Clinical Research Site Director to oversee daily operations and drive the success of advanced cancer trials. This is a unique opportunity to shape the future of oncology studies, influence breakthrough treatments, and contribute directly to improving patient outcomes.

As the Site Director, you will lead clinical teams, strengthen sponsor relationships, and ensure every study meets the highest standards of quality and compliance. Your expertise in oncology research and deep understanding of FDA, 21 CFR, and ICH-GCP regulations will guide the site's continued excellence and innovation.

The ideal candidate is an experienced leader who combines operational skill with compassion for patients and staff. You bring hands-on oncology trial experience, a track record in clinical operations, and the ability to inspire collaboration across all levels of the research process.

What You'll Do:

• Lead and manage all daily site operations and research personnel
• Partner with sponsors to achieve study milestones, timelines, and budgets
• Maintain full adherence to all regulatory and ethical standards
• Develop and enhance patient care and retention strategies
• Monitor key performance metrics and implement process improvements

If you are ready to lead a high-impact oncology research site and make a difference in the future of cancer treatment, apply today and help advance the next generation of life-saving therapies.

Responsibilities
• Site Management: Oversee daily operations of the clinical research site, including study planning, protocol implementation, patient recruitment, data collection, and maintaining regulatory compliance.
• Team Leadership: Manage and mentor a team of approximately 15 Clinical Research Coordinators and 10+ Research Assistants. Provide guidance and training and conduct performance evaluations to ensure high-quality work and adherence to compliance standards.
• Regulatory Compliance: Ensure all clinical research activities comply with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other relevant regulatory requirements.
• Study Execution: Serve as the subject matter expert for sponsors and research organizations, collaborating with the Principal Investigator (PI) to oversee compliance of clinical trial teams in accordance with protocols, timelines, and budgets.
• Patient Recruitment & Retention: Work closely with the recruitment team to develop effective strategies for research participant recruitment and retention, ensuring access to eligible participants and maintaining participant engagement throughout the study.
• Budget & Financial Oversight: Manage study budgets, invoicing, and site expenditures, ensuring effective use of resources while staying within allocated financial parameters.
• Quality Assurance: Ensure data integrity by reviewing audit trails, identifying compliance or quality concerns, and implementing corrective actions. Monitor ongoing site performance to detect risks and take proactive measures.
• Collaboration & Communication: Foster strong communication and collaboration between internal teams, study sponsors, and external stakeholders, ensuring alignment and transparency in the study's progress.
• Clinical Data Management: Oversee the collection and review of clinical data, ensuring strict compliance with study protocols and regulatory requirements.

Qualifications
• Education: Bachelor's degree in life sciences, nursing, or a related field (required). A Master's degree or higher is preferred.
• Experience: Minimum of 5 years of clinical research experience, with at least 2 years in hematology/oncology clinical trials. A minimum of 3 years in a management or leadership role overseeing clinical research teams (CRCs and RAs).
• Certifications: CCRP (Certified Clinical Research Professional), CCRC (Certified Clinical Research Coordinator), or other relevant certifications preferred.
• Knowledge: In-depth understanding of clinical research methodologies, regulatory compliance (FDA, ICH-GCP), and hematology/oncology drug development.
• Skills: Strong leadership, communication, organizational, and problem-solving skills. Proficiency in clinical trial management systems and Microsoft Office Suite.
• Other: Ability to manage multiple priorities in a fast-paced environment while maintaining high standards of performance and patient care.

Compensation: The salary for this position is competitive and positioned within the 80th to 90th percentile for Clinical Research Site Directors in the Los Angeles area, based on experience and qualifications. A comprehensive benefits package is included, covering health, dental, and vision insurance, 401(k), and paid time off.

Work Environment:
• The Clinical Research Site Director will primarily work in a clinical research setting, interacting with patients, site staff, and external stakeholders.
• Occasional travel to sponsor meetings or other clinical sites may be required.
• Full-time position with flexible hours based on study needs.