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Senior Clinical Trial Safety Associate, Toronto/Markham, Ontario, Canada Location

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 Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. 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 Senior Clinical Trial Safety Associate for our Toronto/Markham, Ontario, Canada location.

Key Accountabilities:

  1. Process, review, and assess SAE, device incident, and pregnancy reports from clients’ ongoing drug or device clinical trials in a timely manner. Case processing includes, but is not limited to, the following:
  2. Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  3. Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned safety monitoring projects. The project information may include the study protocol, case report forms, Investigator’s Brochure, etc.
  4. Assume a leader/mentorship role in the training of safety associates for clinical safety monitoring activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
    • Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports, assess cases for completeness, and generate queries for any critical or missing information.
    • Perform data entry of safety cases into the safety database or perform QC review of data in the safety database entered by another safety associate.
    • Through review of patient data including demographic, medical history, concomitant medication, and adverse event data and supplemented by supplementary reports (e.g., hospital discharge summary), write and maintain up-to-date, complete, and concise case narratives based on initial and follow-up reports received. Perform QC review of narratives written by other safety associates.
    • Complete regulatory report forms (MedWatch/CIOMS) for reportable events for clients’ submission to regulatory authorities and Investigators/IRBs.
    • Interact with the Everest Medical Monitor to produce high quality case narratives and regulatory report forms that conform to Everest’s standards and regulatory requirements.
  5. Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  6. Write or review study-specific safety management plans.
  7. Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases.
  8. Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  9. Contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), or other documents, as necessary.
  10. Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  11. Perform administrative and project management tasks for DMC/DSMB, according to Everest’s data and safety monitoring SOPs. Administrative and project management tasks may include, but are not limited to, the following:
    • Assist with the identification, recruitment, and engagement of DMC/DSMB members, including contract negotiations, consultant agreements, and administration of honorarium payments.
    • Serve as the liaison between the DMC/DSMB and the sponsor.
    • Coordinate the writing of the DMC/DSMB Charter and its amendments and their review, finalization, and sign-off by the DMC/DSMB and Sponsor.
    • Coordinate the preparation of the DMC/DSMB Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the DMC/DSMB, according to the Charter; including the preparation of project timelines as needed.
    • Plan, schedule, and coordinate all DSMB meetings, produce meeting minutes, and assist the DMC/DSMB Chair with the Recommendations Letter, according to the Charter.
  12. Assist Everest medical writing group by occasionally performing internal QC procedures, according to Everest’s Medical Writing Guidance Documents, for medical writing products such as protocols, clinical study reports (full, abbreviated, or synoptic), statistical reports, and other documents intended for regulatory submission. May perform internal QC procedures for cross-functional documents, including statistical tables, listings, and graphs (TLGs).
  13. Lead or support the Everest medical writing group in the establishment of a new reference library system.
  14. Assist with new SOP development for PV procedures.
  15. Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

Qualifications and Experience:

  1. Bachelor degree in Clinical or Medical or Life Sciences with substantial experience in the subject matter.
  2. At least four years' experience in clinical research with an emphasis on drug safety of clinical trial subjects, from a pharmaceutical/CRO perspective or clinical study site perspective.
  3. Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
  4. Experience with safety case processing of SAEs.
  5. Experience with an accepted clinical data capture and management system.
  6. Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
  7. Computing skills in MS Office applications.
  8. Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  9. Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
  10. Detail-oriented, customer- and quality-focused.
  11. Excellent interpersonal and teamwork skills.

How to Apply:

Please send your application along with cover letter t[email protected]

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com  

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

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