Cancer Clinical Research Coordinator Associate - Pediatric Cancer Cell Therapy

$65,998 - $76,003/Yr

Stanford University - Stanford, CA

Full-time - Entry Level

Stanford, CA

251-500 employees

Educational Services

About the position

The Stanford Cancer Institute (SCI) is a prestigious National Cancer Institute-Designated Comprehensive Cancer Center, recognized for its dynamic and complex environment within the Stanford University School of Medicine. The SCI is dedicated to reducing cancer mortality through comprehensive programs that encompass research, treatment, education, and outreach. With a workforce of over 320 staff members, the SCI fosters a fast-paced, team-oriented atmosphere that encourages personal and professional growth. The Cancer Clinical Trials Office (CCTO) plays a crucial role in translating laboratory research into clinical applications, particularly in the realm of pediatric cancer cell therapy. As a Clinical Research Coordinator Associate, you will be integral to supporting early-phase clinical research studies. This role requires a deep understanding of the SCI's mission and priorities, as well as the ability to work collaboratively with a diverse team of faculty and staff who are at the forefront of cancer care innovation. The ideal candidate will possess excellent organizational skills, attention to detail, and a proactive approach to challenges, demonstrating professionalism and flexibility in a demanding environment. Your responsibilities will include serving as the primary contact for research participants, sponsors, and regulatory agencies, coordinating studies from initiation to completion, and ensuring compliance with research protocols. You will also assist in developing recruitment strategies, manage research project databases, and prepare regulatory submissions. This position offers a unique opportunity to contribute to groundbreaking research while working closely with clinical staff and principal investigators to ensure patient safety and adherence to study protocols.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Coordinate studies from start-up through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.
• Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.
• Manage research project databases, develop flow sheets and other study-related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
• Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

Requirements

• Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
• Knowledge of the principles of clinical research and federal regulations.
• Familiarity with IRB guidelines and regulations.
• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

Nice-to-haves

• Previous experience with clinical trials.
• Previous experience in Cell Therapy or Pediatrics.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Benefits

• Comprehensive health insurance coverage.
• Dental and vision insurance.
• Retirement savings plan with 401(k) options.
• Paid time off and holidays.
• Tuition reimbursement for further education.
• Professional development opportunities.
• Flexible work arrangements including hybrid work options.