Clinical Study Management Associate

North Chicago, IL 60064

Post Date: 03/02/2018 Job ID: 26225 Category: Professional

Job Summary:

The Study Management Associate is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.

  • Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and  company policies and procedures).
  • Supports the Study Project Manager in leading the cross functional study team:
    • Supports the preparation of Clinical Study Team meetings (Agenda/Minutes).
    • Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure CTMS is up to date.
  • Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR).
  • Supports the vendor selection, scope development, management and oversight of external vendors in compliance with client's processes and procedures and the applicable regulations.
  • Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies.
  • Proactively identify and resolve and/or escalate study related issues.
  • Participates in process improvement initiatives.

  • Bachelor's Degree or equivalent is required, typically in nursing or scientific field; Associate's Degree, R.N. Or equivalent with relevant experience is acceptable.
  • Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
  • Possesses good communication skills.
  • Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
  • Preferred exposure to study initiation through study completion.

For more information, please call our office at 877-782-3334.


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