Cancer Clinical Research Coordinator Associate - GynOncology(Hybrid)

Stanford Cancer Institute (SCI) is one of only 49 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country. As an NCI-designated Comprehensive Cancer Center, SCI maintains the highest level of scientific rigor, institutional support, and coordination for 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 (SCI-CTO) is an integral component of SCI, enabling the translation of research from the laboratory into the clinical setting. The SCI employs approximately 275 staff members in a fast-paced environment with opportunities for growth within the Clinical Research teams.

About the role

The Clinical Trials Office in the Stanford Cancer Institute seeks a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies in the Gynecologic Oncology disease area. The incumbent will work with the team to ensure the safety and well-being of trial participants and document related data per protocols and SCI-CTO SOPs and guidelines.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Coordinate studies from start-up through closeout.
• 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.
• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

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.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

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, 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.

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of their job.

Working Conditions

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

Work Standards

• Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• 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 expected to comply with all applicable University policies and procedures.

Must possess and maintain a valid California non-commercial Class C Driver's License. Ability to drive day or night. When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.