The Stanford University CCTO (Cancer Clinical Trials Office) is seeking a Clinical Research Coordinator 2 to work with the department of Radiation-Oncology CRG (Clinical Research Group) to conduct investigator initiated multi-site clinical research studies as well as cooperative group trials. Radiation Oncology is a diverse group and a good candidate must be flexible and will be asked to work on more than one disease site. The candidate must be able to work independently on complex clinical research studies including managing more than one large study.
Oversee and manage all aspects of multi-site investigator initiated trials (7+ sites and 3+sites) including opening new sites, leading SIV meetings, managing regulatory documentation for each site, managing OnCore/SUNet ID access for outside sites, SAE reporting, randomization and eligibility confirmation for outside sites.
Managing local IRB renewals, audit preparation for Stanford and outside sites, keeping outside sites updated on protocol revisions and renewals.
Determine effective strategies for increasing local and outside site recruitment, and maintining long term follow up for local subjects.
Manage data/oversee data management for research projects. Meet DSMC requirements for site management up to date. Develop and manage systems to organize, collect, report, and monitor data collection. Extract and analyze data.
Develop project schedules, keep targets, measurements, and accountabilities, as assigned. Occasionally lead team meetings and prepare/approve minutes.
Formally mentor new staff or students, as assigned, participate in hiring process, prepare or assist 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/SRC/DSMC submissions, and respond to requests and questions.
Collaborate with principal investigators, 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.
Work with CTRU to keep current cooperative group studies up to date and to open new studies.
* - Other duties may also be assigned.
Experience working with oncology clinical research studies. Minimum of 2 years of experience in a clinical research setting
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
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.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Drivers License. Add Here
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.
*- 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 his or her job.
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 disease and infections.
May require extended or unusual work hours based on research requirements and business needs.
WORK STANDARDS (from JDL):
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the Universitys Administrative Guide, http://adminguide.stanford.edu
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains d...edicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu.
Stanford University is an equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.