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 location.
The incumbent will perform case processing and management of serious adverse events (SAEs) and device incident reports in compliance with Everest standard operating procedures (SOPs) and regulatory guidelines related to pharmacovigilance (PV) and medical device vigilance (MDV) activities for our clients. This includes, but is not limited to case triage and assessment, data entry and query generation, data reconciliation, narrative and safety report writing, interactions with clinical study sites, and overall management of cases. Assist with writing or reviewing safety monitoring documents, including safety management plans.
This individual will work closely with multidisciplinary study teams in all aspects of safety data processing, management, and reporting. Support medical writing teams by providing quality control review of medical writing documents, working closely with assigned Everest medical writers, biostatisticians, project managers, and quality control personnel. Support medical writers in the establishment of a new reference library system for company-wide reference management.
- 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 SAEs, device incidents, 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.
- Entering case data into the Argus Safety Database or performing quality reviews of data entered by another Clinical Trial Safety Associate.
- 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 quality control review of data in the safety database.
- May include initial assessment of reportability for expedited reporting.
- Tracking of cases, including receipt of initial and follow-up reports.
- 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) 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.
- Upload supplemental information and communications to the Argus Safety Database for cases.
- Perform User Acceptance Testing (UAT) for modifications made to the Argus Safety Database.
- Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
- Write or review study Safety Management Plans (SMPs) and associated documents.
- Assist with reconciliation of safety data between clinical and safety databases.
- 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), or other documents, as necessary.Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
- Assist Everest Medical Writing and Clinical Safety Monitoring group by occasionally performing internal quality control (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).
- Assist Everest Medical Writing and Clinical Safety Monitoring group in the establishment of a new reference library system.
- Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
Qualifications and Experience:
- BSc degree in Clinical or Medical or Life Sciences.
- At least 2 years’ drug safety experience in a pharmaceutical or CRO environment.
- Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
- Experience with safety case processing of SAEs.
- Experience with an accepted clinical data capture and management system or safety database system.
- Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
- Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
- Detail-oriented, customer- and quality-focused.
- Excellent interpersonal and teamwork skills.
- Computing skills in MS Office applications.
How to Apply:
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.