Clinical Trial Safety Associate

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 a **Clinical Trial Safety 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**:

- 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.
- Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
- 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:

- Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports.
- Perform data entry into the safety database, assessing cases, and generating queries for any critical or missing information.
- Interacting with the study Data Manager to post queries to clinical database, or directly with clinical study sites to obtain the missing case information.
- Performing QC review of data in the safety database.
- May include initial assessment of reportability for expedited reporting.
- 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.
- Generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/IRBs.
- Interact with the Everest Medical Monitor and/or study Medical Monitor to produce high quality case narratives and regulatory report forms that conform to Everest’s standards and regulatory requirements.
- Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
- Write or review sponsor-specific PV case processing procedural manuals and study-specific SMPs.
- Assist with reconciliation of safety data between clinical and safety databases.
- Assist Database Administrator with safety database setup such as performing User Acceptance Testing (UAT), drafting UAT test scripts, and code list QC reviews, etc.
- Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
- Contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other documents, as necessary.
- Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
- 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).
- May also act as a Data Monitoring Committee/Data Safety Monitoring Board (DMC/DSMB) Administrator/Secretary, producing meeting minutes and assisting to plan, organize, and coordinate meetings and serve as the primary contact for day-to-day operations between the members and the Sponsor