Clinical Safety Data Associate I

Everest Clinical Research ( Everest ) 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’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

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.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength that’s us that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Clinical Safety Data Associate for our Toronto / Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities :

• Develop study safety data review plans and maintain a standard set of data review checklists for clinical trial laboratory data, 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 to the Clinical Data Manager with writing the Laboratory Edit Specifications, review the specifications to confirm accuracy, completeness, and ensure consistency across all studies.

Review clinical trial laboratory data according to the standard review checklist(s) and interact with the Clinical Data Manager to resolve issues identified during the review.

• Review and confirm laboratory normal ranges and units from both central laboratories and local laboratories. Interact with the Clinical Data Manager, Laboratory, or Clinical Site Monitor to ensure accuracy and consistency of the ranges and units.
• Coordinate with and assist the Clinical Data Managers in managing local and central laboratory data and resolve related data issues.
• Assist the Director of Medical Coding to ensure proper version control of the coding dictionaries and keep track of trial Sponsors’ requirements on coding dictionaries and ensure compliance on these requirements.
• Participate in and contribute to Clinical Data Management initiatives.
• Provide medical and coding support for programming and biostatistics activities and projects as required and needed.

Qualifications and Experience :

• RN, M.D., M.Sc., or Ph.D. in Pharmacology or in health related science, Pharm.D., or equivalent education in relevant disciplines.
• Two to three years’ experience in clinical trial data management, including medical coding and laboratory data management.
• A broad knowledge in clinical trial safety data coding and management.
• Demonstrated ability to effectively manage medical information; must communicate effectively, orally and in writing, with personnel on all professional and administrative levels;

must be well organized and able to work independently and manage multiple projects / tasks appropriately.