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Lead Clinical Research Coordinator – BMT
2 months ago
Position Overview:
The Stanford Cancer Institute (SCI) stands as a distinguished National Cancer Institute-Designated Comprehensive Cancer Center, recognized for its innovative approach within the Stanford University School of Medicine. Our mission is to combat cancer mortality through extensive research, treatment, education, and outreach initiatives. We are seeking a Clinical Research Supervising Lead (CRC3) to contribute to this vital mission. The SCI is a dynamic and collaborative environment, employing over 320 professionals dedicated to advancing cancer care and research.
Key Responsibilities:
- Manage and oversee all facets of clinical trials, including both industry-sponsored and investigator-initiated studies.
- Direct subject recruitment efforts and establish effective strategies for participant engagement and retention in long-term studies.
- Supervise data management processes for research projects, ensuring compliance with regulatory standards and maintaining organized systems for data collection and reporting.
- Maintain comprehensive regulatory files in accordance with Clinical Trials Office guidelines.
- Develop project timelines and lead operational meetings, ensuring clear communication and documentation of proceedings.
- Mentor new team members and assist in the hiring process, contributing to performance evaluations and project-related training.
- Conduct audits to ensure adherence to regulatory requirements and implement corrective actions as necessary.
- Collaborate with principal investigators to monitor serious adverse events and address study-related inquiries.
- Provide leadership in refining policies and processes, establishing best practices for clinical research.
- Assist in budget development for studies, tracking milestones and managing billing processes in line with study contracts.
- Ensure ongoing regulatory compliance through regular inspections of study documentation and preparation for audits.
- Work closely with investigators to facilitate Institutional Review Board renewals.
Desired Qualifications:
- Experience in oncology and blood and marrow transplantation trial coordination.
- Familiarity with hospital or clinic site coordination.
Education & Experience (Required):
A Bachelor's degree in a relevant field coupled with four years of clinical research experience, or an equivalent combination of education and experience.
Knowledge, Skills, and Abilities (Required):
- Exceptional interpersonal skills.
- Proficiency in Microsoft Office and various database applications.
- Understanding of research protocols and regulatory requirements, including HIPAA and FDA regulations.
- Knowledge of medical terminology.
- Demonstrated leadership capabilities in project and program management.
- Experience in study design and disease knowledge relevant to the research conducted.
Certifications & Licenses:
Preferred certification from the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Physical Requirements:
- Ability to frequently stand, walk, bend, and perform fine motor tasks.
- Occasional requirements to sit, reach, and perform desk-based tasks.
- Capability to lift and carry objects weighing up to 40 pounds.
Working Conditions:
- Potential exposure to bloodborne pathogens.
- Willingness to work non-standard hours as needed for research activities.
Work Standards:
- Demonstrated ability to collaborate effectively with colleagues and external organizations.
- Commitment to safety and adherence to all relevant policies and procedures.
