Cancer Clinical Research Coordinator 2 – Breast and Genomics

Dev•Stanford, CA

2d•$80,000 - $92,000•Hybrid

About The Position

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Coordinator 2 to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI’s mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. Reporting to Clinical Research Manager, the Clinical Research Coordinator 2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to oversee complex clinical research trials. We are seeking candidates with excellent people and time management skills. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. Responsibilities include trial oversight and ensuring accrual targets are met.

Requirements

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Strong interpersonal skills
Proficiency with Microsoft Office and database applications.
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
Knowledge of medical terminology.

Nice To Haves

Oncology clinical trial coordination experience
Investigator Initiated clinical trial coordination experience
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
May require a valid California Driver’s License.

Responsibilities

Oversee subject recruitment and study enrollment goals.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
Oversee data management for research projects.
Develop and manage systems to organize, collect, report, and monitor data collection.
Extract, analyze, and interpret data.
Develop project schedules, targets, measurements, and accountabilities, as assigned.
Lead team meetings and prepare/approve minutes.
Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
Monitor Institutional Review Board submissions, and respond to requests and questions.
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
Develop study budget with staff and principal investigator, identifying standard of care versus study procedures.
Track patient and study specific milestones, and invoice sponsors according to study contract.
Ensure regulatory compliance.
Regularly inspect study document to ensure ongoing regulatory compliance.
Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable.
Ensure Institutional Review Board renewals are completed.
Other duties may also be assigned