Clinical Research Coordinator Associate - Melanoma

Clinical Research Coordinator Associate – Melanoma (Hybrid)

The Stanford Cancer Institute (SCI) is one of only 49 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country. As a NCI-designated Comprehensive Cancer Center, SCI maintains the highest level of scientific rigor and institutional support for cancer-related research across basic, translational, clinical, and population-based science. SCI brings together faculty with cancer-relevant expertise from four schools and over 30 departments throughout the university, employing approximately 275 staff, including the Clinical Trials Office (CTO), to translate research from the laboratory into the clinical setting.

The Clinical Trials Office in the Stanford Cancer Institute at Stanford University’s School of Medicine seeks a Clinical Research Associate to coordinate clinical studies in the Melanoma-Oncology disease area. The incumbent will work closely with the team to ensure the safety and well-being of trial participants and to document related data per protocols, CCTO SOPs, and guidelines.

• 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 documents, and complete study case report forms.
• Ensure compliance with research protocols; 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 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 quality/regulatory audits.
• Hybrid work agreement.

• Knowledge of the principles of clinical research and federal regulations.
• Familiarity with IRB guidelines and regulations.
• Previous experience with clinical trials.
• Professional certification or clinical coordinator internship preferred.

Two‑year college degree and two years related work experience, or a bachelor’s degree in a related field, or an equivalent combination of education and experience.

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

• Frequently stand, walk, twist, bend, stoop, squat, and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk‑based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts; rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

• Position may require working with or in areas where hazardous materials or exposure to chemicals, blood, body fluids, tissues, and risk of contagious diseases and infections occur.
• May require extended or unusual work hours based on research requirements and business needs.

• Interpersonal
  
  Skills:
  
  Demonstrates the ability to work well with Stanford colleagues, clients, and external organizations.
• Promote Culture of Safety:
  Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and…