Clinical Research Coordinator 2

Job description

Clinical Research Coordinator 2🔍School of Medicine, Stanford, California, United States📁Research📅Oct 07, 2020 Post Date📅87483 Requisition #Cancer Clinical ResearchCoordinator 2

The Stanford Cancer Institute (SCI) is one of an elitenumber of National Cancer Institute-Designated Comprehensive Cancer Centers inthe country, and is a prominent, dynamic, growing and complex Institute withinthe Stanford University School of Medicine. The SCI actively works to build synergies and collaborations amongfaculty with cancer-relevant expertise from four Schools and over 30departments across Stanford University. We seek a Clinical Research Coordinator 2 to help us enact our mission to reduce cancermortality through comprehensive programs of cancer research, treatment,education and outreach. Given the SCI’smission, breadth, and depth, it employs over 320 staff members in a fast-paced,team-oriented, and forward-thinking environment with tremendous opportunitiesfor personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of theStanford Cancer Institute since the vital work performed there enables ouradult and pediatric cancer centers to translate research from the laboratoryinto the clinical setting. You will beworking with an unparalleled leading edge community of faculty and staff whoare fundamentally changing the world of health care in the cancer arena.

Reporting to Clinical Research Manager, the ClinicalResearch Coordinator 2 willbe conversant in the goals, mission and priorities of the Institute, andutilize this knowledge to oversee complex clinical research trials. We are seeking candidates with excellentpeople and time management skills. Ourstaff run toward challenges, and you will have a demonstrated history of doingthe same with a high degree of professionalism, initiative andflexibility. Responsibilities includetrial oversight and ensuring accrual targets are met.

Duties include:
  • 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 assignedDESIREDQUALIFICATIONS:

    Oncology clinical trial coordination experienceInvestigator Initiated clinical trial coordinationexperience

    EDUCATION &EXPERIENCE (REQUIRED):

    Bachelor's degree in arelated field and two years of experience in clinical research, or anequivalent combination of education and relevant experience.

    KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
    • Strong interpersonalskills
    • Proficiency withMicrosoft Office and database applications.
    • Experience with researchprotocols and regulatory or governing bodies, which include HIPAA and FDAregulations, Institutional Review Board requirements, and Good ClinicalPractices.
    • Knowledge of medicalterminology.
    CERTIFICATIONS &LICENSES:

    Societyof Clinical Research Associates or Association of Clinical ResearchProfessionals certification is preferred. May require a valid CaliforniaDriver’s License.

    PHYSICAL REQUIREMENTS*:
    • Frequently stand, walk,twist, bend, stoop, squat and use fine light/fine grasping.
    • Occasionally sit, reachabove shoulders, perform desk based computer tasks, use a telephone and writeby 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 itsobligations under the law, the University will provide reasonable accommodationto any employee with a disability who requires accommodation to perform theessential functions of his or her job.

    WORKING CONDITIONS:
    • Position may at timesrequire the employee to work with or be in areas where hazardous materialsand/or exposure to chemicals, blood, body fluid or tissues and risk of exposureto contagious diseases and infections.
    • May require extended orunusual work hours based on research requirements and business needs.
    WORK STANDARDS:
    • Interpersonal Skills:Demonstrates the ability to work well with Stanford colleagues and clients andwith external organizations.
    • Promote Culture ofSafety: Demonstrates commitment to personal responsibility and value forsafety; communicates safety concerns; uses and promotes safe behaviors based ontraining and lessons learned.
    • Subject to and expectedto comply with all applicable University policies and procedures, including butnot limited to the personnel policies and other policies found in theUniversity's Administrative Guide, http://adminguide.stanford.edu.
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    Job No:
    Posted: 10/8/2020
    Application Due: 12/7/2020
    Work Type:
    Salary: