"Cancer 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 the SCI is a dynamic and stimulating place to work as it maintains the highest level of scientific rigor, institutional support and coordination for the complete range of cancer-related research, including basic, translational, clinical and population-based science. The SCI brings together faculty with cancer-relevant expertise from four Schools and over 30 departments throughout the University. The Stanford Cancer Institute Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our cancer center to translate research from the laboratory into the clinical setting. Given the SCI’s mission, breadth, and depth it employs ~275 staff members (inclusive of the CTO) in a fast-paced environment with tremendous opportunities for our Clinical Research teams.

The Clinical Trials Office in the Stanford Cancer Institute, in Stanford University’s School of Medicine seeks a Clinical Research Associate to perform duties related to the coordination of clinical studies in the Melanoma-Oncology disease area. The incumbent will work with the team to ensure the safety and well-being of trial participants and to document related data per protocols and CCTO SOPs and guidelines. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.

Core duties include:

• 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 quality/regulatory audits.
• Hybrid work agreement.

Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• 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.

EDUCATION & EXPERIENCE (REQUIRED):

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, SKILLS AND ABILITIES (REQUIRED):

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

PHYSICAL REQUIREMENTS:

• 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.

WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

The expected pay range for this position is $34.56 to $40.30 per hour.