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Clinical Research Coordinator 2 - Study Start Up (Hybrid Opportunity)

Stanford University
Stanford, USA
Full-time
Entry · 2+ years experience
Hybrid
USD 72306.05-134971.28 yearly / year
Discovered 2 weeks ago
Microsoft OfficeInstitutional Review BoardFDAHIPAA
Free

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Responsibilities

  • Core Duties :
  • 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 documents 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.
  • Minimum Education and Experience
  • 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 :
  • Strong interpersonal skills.
  • Proficiency in 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.
  • Certificates and Licenses Required
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Qualifications

  • [REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE. REMOVE IF NOT APPLICABLE]
  • Drivers License Requirements
  • Must possess and maintain a valid California non-commercial Class C Driver's License.
  • Ability to drive day or night.
  • When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

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