Study Management Associate II/III

  • location: North Chicago, IL
  • type: Contract
  • salary: $45 - $55.46 per hour
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job description

Study Management Associate II/III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

location: North Chicago, Illinois
job type: Contract
salary: $45.00 - 55.46 per hour
work hours: 9 to 5
education: Bachelors
  • Study Management Associates (SMAs) are responsible for supporting the planning and execution of one or more Phase 1 - 4 clinical research studies. An 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. Core Activities include:
  • 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 our 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 Company'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
  • Bachelor's Degree or OUR equivalent is required, typically in nursing or scientific field; or R. N. by Associate's Degree 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.
skills: SOP, MS-WORD, MS-EXCEL, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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