Clinical Research Coordinator 2

Job description

Clinical Research Coordinator 2🔍School of Medicine, Stanford, California, United States📁Research📅Aug 07, 2020 Post Date📅87024 Requisition #ClinicalResearch Coordinator 2 (Lymphoma)

The StanfordCancer Institute (SCI) is one of an elite number of National CancerInstitute-Designated Comprehensive Cancer Centers in the country, and is aprominent, dynamic, growing and complex Institute within the StanfordUniversity School of Medicine. The SCI actively works to build synergiesand collaborations among faculty with cancer-relevant expertise from fourSchools and over 30 departments across Stanford University. We seek a ClinicalResearch Coordinator 2 to help us enact our mission to reduce cancer mortalitythrough comprehensive programs of cancer research, treatment, education andoutreach. Given the SCI’s mission, breadth, and depth, it employs over320 staff members in a fast-paced, team-oriented, and forward-thinkingenvironment with tremendous opportunities for personal and professionalgrowth. The Cancer Clinical Trials Office (CCTO) is an integral componentof the Stanford Cancer Institute since the vital work performed there enablesour adult and pediatric cancer centers to translate research from thelaboratory into the clinical setting. You will be working with anunparalleled leading edge community of faculty and staff who are fundamentallychanging the world of health care in the cancer arena.

Reporting to the Lymphoma 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 overseethe regulatory maintenance and conduct of clinical trials. We areseeking candidates with excellent Organizational, Interpersonal andCommunication Skills. Our staff run toward challenges, and you will havea demonstrated history of doing the same with a high degree of professionalism,initiative and flexibility. Responsibilities include frequentinterface and communication with study participants, clinicians and otherstakeholders.

Dutiesinclude:

  • 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
    DESIREDQUALIFICATIONS: Prior experience with: patientmanagement on cancer treatment trials; financial and regulatory oversight ofclinical trials; navigating patient electronic medical records.

    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 withresearch protocols and regulatory or governing bodies, which include HIPAA andFDA regulations, 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 its obligations under the law, the University will providereasonable accommodation to any employee with a disability who requiresaccommodation to perform the essential 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: 8/9/2020
    Application Due: 9/10/2020
    Work Type:
    Salary: