Bighorn Law
An exciting leadership role is open for a Clinical Research Site Director to oversee operations at a hematology/oncology research site in Los Angeles, CA. This position offers the chance to play a vital role in innovative cancer studies and drive impactful work in clinical research. In this role, youll lead a dedicated site team, coordinate with sponsors, and ensure that clinical trials are executed smoothly and in full compliance with FDA/21 CFR and ICH-GCP standards. Your leadership will directly contribute to advancing treatment options in hematology and oncology. We're seeking an experienced professional with a strong background in clinical trial management and deep knowledge of oncology research. Ideal candidates will bring proven leadership skills, regulatory know-how, and a passion for improving patient outcomes through research. Primary Duties: Manage and support daily site operations and research staff Partner with study sponsors to meet study objectives Ensure regulatory compliance across all research activities Promote a culture of excellence in participant care Monitor timelines and overall trial performance If you're ready to lead meaningful work at the cutting edge of cancer research, apply now and be part of shaping the future of oncology care. 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 studys 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. Compensation: $145,000 - $165,000 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 studys progress. Clinical Data Management: Oversee the collection and review of clinical data, ensuring strict compliance with study protocols and regulatory requirements.
Compensation: $145,000-$165,000 per year
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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 studys 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. Compensation: $145,000 - $165,000 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 studys progress. Clinical Data Management: Oversee the collection and review of clinical data, ensuring strict compliance with study protocols and regulatory requirements.
Compensation: $145,000-$165,000 per year
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