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Stanford University School of MedicinePosted 29 days ago

Live Support, Clinical Research Operations Specialist II (REACT) (Remote Opportunity)

Full-time
Remote
2+ years
Competitive
Posted 29 days ago

Live Support, Clinical Research Operations Specialist II (REACT) (Remote Opportunity)

Health Care

Posted
29 days ago
Source
careersearch.stanford.edu
Sector
Legal Services

Opens the employer's application page in a new tab

Responsibilities

  • 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
  • Providing study sites with live support for time-sensitive requests
  • Leading efforts in collection of participant safety data
  • Reviewing study Operations Manuals and Documents
  • Providing non-urgent support to study sites that impact enrollment and safety

Qualifications

  • Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience
  • 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
  • Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Preferred

  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred

Required skills

Clinical ResearchMicrosoft OfficeHIPAAFDA RegulationsClinical PracticeMedical Terminology

Full job description

Live Support, Clinical Research Operations Specialist II (REACT) (Remote Opportunity)

Health Care

  • Biotechnology
  • Healthcare
  • Medical

Responsibilities

  • 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
  • Providing study sites with live support for time-sensitive requests
  • Leading efforts in collection of participant safety data
  • Reviewing study Operations Manuals and Documents
  • Providing non-urgent support to study sites that impact enrollment and safety

Preferred

  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred

Benefits

  • This is a remote position.
  • Support to acquire new skills and grow within the organization.
  • Support to achieve a healthy balance between work commitments and life outside of work.
  • Glassdoor
  • 4.0
  • Medical school and hospitals for research, education, and clinical care.
  • Stanford, California, USA
  • https://med.stanford.edu/scgpm.html
  • Late Stage
  • Leadership Team
  • Laila Soudi
  • Co-Founder, Co-Director MENA Health Program
  • Monica Hanson
  • Co-Founder and Director, (ACT), CCARE, Research Center at Stanford School of Medicine
  • Recent News
  • Business Wire
  • The Foundation for the National Institutes of Health Announces Recipients of the Deeda Blair Research Initiative for Disorders of the Brain
  • 2026-05-20
  • BioSpace
  • NeuroDex and Stanford Researchers Publish First Evidence of CNS Target Engagement for GLP-1 and PPARγ Agonists Using Blood-Based Neuron-Derived Extracellular Vesicles
  • 2026-04-23
  • News-Medical.Net
  • AI predicts retinal age to identify early signs of biological aging
  • 2026-04-22
  • Company data provided by
  • AI Tools
  • Customize Your Resume
  • Maximize your interview chances
  • Build Cover Letter
  • Make your application stand out

Qualifications

  • Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience
  • 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
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
  • Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Required skills

  • Clinical Research, Microsoft Office, HIPAA, FDA Regulations, Institutional Review Board Requirements, Clinical Practice, Medical Terminology, Society of Clinical Research Associates Certification, Association of Clinical Research Professionals Certification

Experience

  • 2+ years

Job details

Employment type

Full-time

Seniority level

2+ years

Date posted

Oct 15, 2026

Work mode

Remote

Job source

careersearch.stanford.edu

Company

Stanford University School of Medicine

Legal Services

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Live Support, Clinical Research Operations Specialist II (REACT) (Remote Opportunity)

Stanford University School of Medicine · Competitive

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