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Clinical Research Assoc.: Fladger Associates

Company NameFladger Associates
Job CategoryPharmaceutical/Biotech; Science/Research
LocationMalvern, PA • Raynham, MA • Jacksonville, FL
Position TypeFull-Time, Contract
Salary$30 to $40 per hour
Experience2-5 Years Experience
Desired Education LevelBachelor's degree
Date PostedOctober 11, 2009 (Reposted Nov 14)
Fladger Associates
View Fladger Associates profile and job listings

  • Ensure the CRO Oversight Plan is completed and incorporated as part of the clinical trial plan for selected Clinical Trials executed by GCO. Under the GTM coordination, this position must concentrate on the early and continuous detection of quality signals; log quality and progress issues that can put the trial at risk and implement specific actions together with the relevant stakeholders to correct and mitigate them.
  • Ensure the Local GCP Managers or designees, involved in the On-site Quality Monitoring visits on all relevant trial specific aspects, are adequately trained
  • Review the Progress and Quality metrics provided by the CRO as agreed in the CRO Oversight Plan versus the agreed project timelines and quality
  • Review a proportion of the Monitor Visit Reports (including pre-trial and initiation reports) as specified in the Quality Oversight Plan. Identified issues will be documented and followed-up till resolution on the Issue Escalation and Mitigation Plan.
  • Review the On-site Quality Monitoring Visit Reports, generated by the Local GCP Manager or designee, as specified in the Quality Oversight Plan. Identified issues will be documented and followed-up till resolution on the Issue Escalation and Mitigation Plan.
  • Review the trial specific Audit Reports as specified in the Quality Oversight Plan. If information is obtained that requires action in addition to the CAPA, the issues will be documented and followed-up till resolution on the Issue Escalation and Mitigation Plan.

Qualifications

­Working in a matrix environment BS degree required, preferred in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or equivalent by experience

Minimum of 3 years related clinical trials experience in the pharmaceutical industry, as a clinical trials professional

For Jr. position 1-2 years of exp.

Strong knowledge on ICH-GCP and international regulations and guidelines governing trial execution.

Strong operational expertise and quality control knowledge, project planning, strong organization skills, and excellent decision-making are essential to this position

Effective leadership skills and proven ability to foster team productivity and cohesiveness. Excellent communication skills and the innate flexibility to work in a rapidly growing organization. Computer literacy is also required




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