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Testing & Laboratory
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029849 Requisition #
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The CRA / Sr. CRA performs project activities related to monitoring for phase I-IV (national and international) clinical studies. Major responsibilities include ensuring the safety and well-being of study subjetcs at assigned site(s); ensuring site(s) compliance with study plans and guidelines, Good Clinical Practices (GCPs), and applicable regulations. S/he maintains an effective communication with the assigned clinical trial sites, thereby contributing to the overall management of the trials. The CRA/Sr.CRA works under immediate supervision of the Led CRA and the CRA Manager
 
Essential functions of the CRA / Sr. CRA include:
 
Monitoring
  • Participates in the identification of potential investigators and clinical sites
  • Performs Investigator site visits relevant to the phase of the study (selection and qualification, initiation, regular monitoring or site closure) as specified in the Project and Monitoring plan
  • Drives site performance, engagement and recruitment through regular communications and by setting clear expectations, providing feedback and developing action plans for remediation when needed
  • Ensures compliance with the protocol requirements, ICG-GCP, and the applicable local regulations
  • Identifies protocol deviations and related action items, tracks them in the  Clinical Trial Management System and follows these up until resolution
  • Ensures timely reporting of adverse events and protocol deviations
  • Ensures proper storage, dispensation and accountability of all investigational products and trial-related supplies
  • Ensures timely completion of the Case Report Forms and data queries, if applicable
  • Maintains appropriate documentation regarding monitoring activities, visit findings, deviations and action items by timely visit reports, follow up letters and other applicable study documentation
  • Updates visit, site and patient related information in the (CTMS)
  • May conduct field training and assessment of less experienced CRAs
 
Administrative
  • Assists with the development essential study documents such as informed consent forms, monitoring plan and other study startup or management material and tools
  • May be responsible for compiling and submitting regulatory packages to IRB or competent authorities
  • Participates in project team meetings and project training
  • Assist in protocol feasibility assessments
  • Assists with the development of newsletters and project updates

Attends the investigator meetings and may present at

Qualifications
  • BS (or equivalent) in science related field
  • Excellent command of FDA CFR21 (parts 11, 50, 54, 56, 312, and 314)
  • At least 1 year (CRA) / 4 years (Sr. CRA) site management and monitoring experience within pharmaceutical, biotech or CRO setting, having monitored phase 2 and 3 multi-center studies
  • Strong organizational skills to cope with multi-tasking which result in a goal-oriented approach without losing the attention to detail
  • Excellent communication skills (written and oral), time management and organizational skills, and problem-solving skills
  • Willingness to travel (domestic and international) as needed
  • Good computer skills:  Word, Excel, PowerPoint, Outlook
  • Ability to prioritize and to manage multiple tasks as necessary

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