Clinical Safety Data Associate

3 weeks ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research Services Inc. is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Key Accountabilities:

  • Develop study safety data review plans and maintain a standard set of data review checklists for clinical trial laboratory data, adverse events (AEs), serious AEs (SAEs), medical events of special interests, concomitant medications, disease history, and early study termination due to AEs.
  • Perform safety data review according to the Safety Data Review Plan and review safety data in study database, including the review of laboratory data, AEs, SAEs, medical events of special interests, concomitant medications, disease history, and early study termination due to AEs. Follow up on issues identified during the review until they are resolved.
  • Coordinate with study Project Managers and Clinical Data Managers to maintain high-quality data collected in clinical trials. Document, report, and follow-up on all issues identified during the review in a timely manner.
  • Provide medical advice when required to the Clinical Data Managers for their work in reconciling SAEs.
  • Perform coding of AEs/medical histories/concomitant diseases using the MedDRA dictionary.
  • Perform coding of medications (e.g., concomitant medications, concomitant therapies, etc.) using the WHODrug dictionary.
  • Coordinate with Data Managers and ensure medical events and medications collected in study database are coded accurately and on a timely basis.
  • Participate in the trial protocol review and the review of trial Case Report Forms (CRFs) or eCRFs (electronic CRFs) and provide input to the requirements for accurate and consistent approaches in laboratory data collection.
  • Provide medical advice when required to the Clinical Data Managers for their work in reconciling SAEs.
  • Perform coding of AEs/medical histories/concomitant diseases using the MedDRA dictionary.
  • Perform coding of medications (e.g., concomitant medications, concomitant therapies, etc.) using the WHODrug dictionary.
  • Coordinate with Data Managers and ensure medical events and medications collected in study database are coded accurately and on a timely basis.
  • Participate in the trial protocol review and the review of trial Case Report Forms (CRFs) or eCRFs (electronic CRFs) and provide input to the requirements for accurate and consistent approaches in laboratory data collection.

Qualifications:

  • Must possess a strong understanding of clinical research principles and practices.
  • Experience with coding adverse events and medical histories using MedDRA is required.
  • Familiarity with the WHODrug dictionary for medication coding is essential.
  • Excellent communication, organizational, and problem-solving skills are crucial.

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