Senior Clinical Research Associate

2 weeks ago

Montreal Quebec, Québec, Canada Barrington James Full time

Canadian based CRA needed for two sites one in Toronto the other in Montreal.


MUST HAVE RECENT ONCOLOGY EXPERIENCE T4 contract only.


0.25 FTE consultant needed for long term project.


Summary


The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.


Responsibilities


  • Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim and closeout.
  • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report for completion.
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
  • Monitoring and documenting investigational product dispensing inventory, and reconciliation.
  • Monitoring and documenting laboratory sample storage and shipment.
  • Monitoring trials by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities.
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
  • Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
  • Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present.
  • Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
  • Following GDPs, completing visit reports and site correspondence in accordance with SOPs.


Requirements


  • Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training.
  • 8-10 years of prior experience as a CRA.
  • Experience in Oncology
  • Ability to travel, including by air or car on short notice.
  • Flexible with changing priorities and excellent organizational skills.

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