Clinical Trial Associate

  • location: North Chicago, IL
  • type: Contract
  • salary: $25 - $30.91 per hour
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job description

Clinical Trial Associate

job summary:
  • Person is responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trial(s); included managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics. Will matrix manage with assigned therapeutic area or functional partners to ensure proper documentation of Company procedures, implementation of process changes, ensure compliance and/or execution on timelines and quality deliverables.
  • Is aware of both internal and external business environments, assesses impact on the processes for clinical study execution and assists in making modification as necessary.
  • Develops initial interpretation of relevant regulations and guidelines initiative to resolve problems and mitigate risk.
 
location: North Chicago, Illinois
job type: Contract
salary: $25.00 - 30.91 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Responsible for compliance with applicable Corporate and Divisional policies and procedures
  • Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators
  • Provides input on new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.
  • Effectively communicates project/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions of solutions to manage the issues.
  • GCP exception management in partnership with the business:

    • Nonconformities
    • Potential nonconformity
    • Planned deviations
  • Issue Escalations for potential significant non-compliance
  • Inspection support
  • Provide consultation on ad-hoc compliance questions
 
qualifications:
  • Bachelor's degree (or equivalent ) is required, typical in nursing or scientific field.
  • An Associate's degree/R.N. with relevant experience is acceptable
  • Must have 6+ years of Pharma-related/clinical research related experience; 2+ years of experience preferably with clinical research, regulatory, compliance and/or quality control
  • Must have demonstrated a high level of core and technical competencies through management of various aspect of clinical trials (e.g., audits, study oversight, SOP development, quality assessments)
  • Possesses good communication skills, demonstrated leadership abilities and problem solving skills
  • Demonstration of successful coaching/mentoring in a matrix environment
  • Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics, and Compliance)
  • Preferred global exposure from study initiation through study completion in multiple phases of studies (Phases 1-3, 4).
 
skills: SOP, Phase I, Phase II, Phase iii, Phase iv, CAPA
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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