Clinical Research Coordinator 2

Employment Type

: Full-Time

Industry

: Miscellaneous



ThePanLab for Precision Psychiatry & Translational Neuroscience located withinthe Department of Psychiatry & Behavioral Sciences at Stanford University’sSchool of Medicine is seeking a Clinical Research Coordinator 2. The PanLab is a clinical neuroscienceresearch group that aims to apply precision medicine approaches to improve ourunderstanding and treatment of mental health conditions such as depression andanxiety.

TheCRC 2 will conduct clinical neuroscience research on several biomarker trialsusing brain imaging, computerized tasks and questionnaires to predict treatmentoutcomes. The focus of these biomarkertrials is on treatments for depression and anxiety that encompasses off labeltherapies such as ketamine and MDMA, neurostimulation techniques such astranscranial magnetic stimulation and accompanying behavioralinterventions. The main goal of thesetrials are to identify biomarkers that allow us to tailor interventions toindividuals based on their brain profile and to understand the mechanisms ofintervention.

Duties include:
  • Oversee subject recruitment andstudy enrollment goals. Determine effective strategies for promoting/recruitingresearch participants and retaining participants in long-term clinical trials.
  • Oversee data management forresearch projects. Develop and manage systems to organize, collect, report, andmonitor data collection. Extract, analyze, and interpret data.
  • Develop project schedules, targets,measurements, and accountabilities, as assigned. Lead team meetings andprepare/approve minutes.
  • Formally supervise, train, and/ormentor new staff or students, as assigned, potentially including hiring,preparing or assisting with the preparation of performance evaluations, andperforming related duties, in addition to instruction on project work.
  • Audit operations, includinglaboratory procedures, to ensure compliance with applicable regulations;provide leadership in identifying and implementing correctiveactions/processes. Monitor Institutional Review Board submissions, and respondto requests and questions.
  • Collaborate with principalinvestigators 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 bestpractices.
  • Develop study budget with staff andprincipal investigator, identifying standard of care versus study procedures.Track patient and study specific milestones, and invoice sponsors according tostudy contract.
  • Ensure regulatory compliance.Regularly inspect study document to ensure ongoing regulatory compliance.
  • Work with principal investigator toensure Investigational New Drug applications are submitted to the FDA whenapplicable. Ensure Institutional Review Board renewals are completed.
  • * - Other duties may also be assigned

    DESIREDQUALIFICATIONS:

  • Previous experience in clinical neuroscience research and/or biomarker trials
  • Previous experience managing clinical trials within the mental health arena
  • Ability to be proactive, solution-focused, efficient, self-directed, adaptable and organized
  • EDUCATION& EXPERIENCE (REQUIRED): Bachelor's degree in a related field and two years of experience inclinical research, or an equivalent combination of education and relevantexperience.

    KNOWLEDGE, SKILLSAND 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 ClinicalResearch Professionals certification is preferred. May require a validCalifornia Driver’s License.

    PHYSICALREQUIREMENTS*:

  • Frequently stand, walk, twist,bend, stoop, squat and use fine light/fine grasping.
  • Occasionally sit, reach aboveshoulders, perform desk based computer tasks, use a telephone and write byhand, 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 thelaw, the University will provide reasonable accommodation to any employee witha disability who requires accommodation to perform the essential functions ofhis or her job.

    WORKINGCONDITIONS:

  • 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.
  • Mayrequire extended or unusual work hours based on research requirements andbusiness needs.
  • WORK STANDARDS 
  • InterpersonalSkills: Demonstrates the ability to work well with Stanford colleagues andclients and with external organizations.
  • PromoteCulture of Safety: Demonstrates commitment to personal responsibility and valuefor safety; communicates safety concerns; uses and promotes safe behaviorsbases on training and lessons learned.

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