Clinical Research Coordinator 2

Job description

Clinical Research Coordinator 2🔍School of Medicine, Stanford, California, United States📁Research📅Oct 14, 2020 Post Date📅87542 Requisition #ClinicalResearch Coordinator 2

TheStanford Cancer 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 SCIactively works to build synergies and collaborations among faculty withcancer-relevant expertise from four Schools and over 30 departments across StanfordUniversity. We seek a Clinical ResearchCoordinator 2 to help us enact our mission to reduce cancer mortality throughcomprehensive programs of cancer research, treatment, education andoutreach. 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 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.

Reportingto the Hematology Clinical Research Manager (CRM), the CRC2 will be conversantin the goals, mission and priorities of the Institute, and utilize thisknowledge to ensure the safety and well-being of trial participants. We areseeking candidates with excellent interpersonal skills and attention to detail. Our staff run toward challenges, and you willhave a demonstrated history of doing the same with a high degree ofprofessionalism, initiative and flexibility.

Duties include:
  • Oversee and manage allaspects of clinical trials including industry and investigator initiated trials.,includingsubsites , if applicable
  • Oversee subject recruitment and study enrollment goals.Determine effective strategies for promoting/recruiting research participantsand retaining participants in long-term clinical trials.
  • Manage data/overseedata management for research projects. Meet DSMC requirements for sitemanagement up to date. Develop and manage systems to organize, collect, report,and monitor data collection. Extract and analyze data.
  • Maintain siteregulatory file,per CCTO guidelines.
  • Develop projectschedules, keep targets, measurements, and accountabilities, as assigned. Occasionallylead team meetings and prepare/approve minutes.
  • Formally mentor newstaff or students, as assigned, participate in hiring process, prepare orassist with the preparation of performance evaluations and performing relatedduties, in addition to instruction on project work.
  • Audit operations,including laboratory procedures, to ensure compliance with applicableregulations; provide leadership in identifying and implementing correctiveactions/processes. Monitor Institutional Review Board/SRC/DSMC submissions, andrespond to requests and questions.
  • Collaborate withprincipal investigators, monitor and report serious adverse events, and resolvestudy queries.
  • Provide leadership indetermining, recommending, and implementing improvements to policies/processes;define best practices.
  • Develop study budgetwith staff and principal investigator, Track patient and study specific milestones, review patient billing andinvoice sponsors according to study contract. Ensure regulatory compliance.Regularly inspect study document to ensure ongoing regulatory compliance.Manage audit preparation of clinical trials at Stanford and subsites. Provideoversight to subsites.
  • Work with principalinvestigator to ensure Investigational New Drug applications are submitted tothe FDA when applicable. Ensure Institutional Review Board renewals arecompleted.
* - Other duties may also be assignedDESIRED QUALIFICATIONS:

Experience working with oncology clinical research studies. Minimum of 2 years of experience in aclinical research setting

EDUCATION& EXPERIENCE (REQUIRED): Bachelor'sdegree in a related field and two years of experience in clinical research, oran equivalent combination of education and relevant experience.


KNOWLEDGE, SKILLS ANDABILITIES (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: Societyof Clinical Research Associates or Association of Clinical Research Professionalscertification is preferred. May require a valid California Driver’s License. Add Here

    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.
    *- Consistentwith its obligations under the law, the University will provide reasonableaccommodation to any employee with a disability who requires accommodation toperform the essential functions of his or her job.

    WORKING CONDITIONS:
    • positionmay at times require the employee to work with or be in areas where hazardousmaterials and/or exposure to chemicals, blood, body fluid or tissues and riskof exposure to contagious disease and infections.
    • May require extended orunusual work hours based on research requirements and business needs.
    WORK STANDARDS:
    • Interpersonal Skills: Demonstratesthe ability to work well with Stanford colleagues and clients and with externalorganizations.
    • Promote Culture ofSafety: Demonstrates commitment to personal responsibility and value for safety;communicates safety concerns; uses and promotes safe behaviors bases 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: 10/15/2020
    Application Due: 12/14/2020
    Work Type:
    Salary: