Clinical Research 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 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 committed, skilled, and customer-focused individuals to join our winning team 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

1. Serve as the DMC Secretary and perform hands-on administrative tasks for assigned projects, according to Everest's SOPs. These tasks include:
   • Assist with the identification, recruitment, and engagement of committee members.
   • Serve as the liaison between the committee and the sponsor.
   • Write the committee Charter and its amendments.
   • Assist with coordinating the preparation of the committee Data Reports.
   • Plan, schedule, and coordinate all committee meetings, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter.
2. Support project management of DMC area with activities focused on planning and execution of DMC administration tasks and biostatistical support.
3. Manage the planning, implementation, conduct, and reporting of assigned projects within established timelines and budgets.
4. Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors.
5. Support medical writing and clinical safety monitoring teams by performing quality control (QC) review of document deliverables.
6. Under supervision, perform medical writing tasks, including writing simple clinical study reports, study protocols, and other regulatory documents.
7. Perform data verification (QC) on statistical programming outputs against data source.
8. Perform consistency review of document formats, styles, and overall layout.
9. Learn and perform document e-publishing for clinical trial and regulatory documents.
10. May assist with case processing of safety events (SAE and/or pregnancy reports).
    • Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms.
    • Entering case safety data into the safety database and generating queries.
    • Interacting with the Lead Safety Associate to post queries.
    • Performing quality control review of data in the safety database.
11. May assist with reconciliation of safety data between clinical and safety databases.
12. Keep current on the training of Everest Guidance Documents and industry guidelines.

Qualifications and Experience

1. M.Sc. or Ph.D. in a clinical or medical or health-related field.
2. At least two years' clinical research experience in an academic, pharmaceutical, or CRO environment.
3. Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards.
4. Experience with an accepted clinical data capture and management system (preferred).
5. Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
6. Good organizational skills with the ability to adapt and adjust to changing priorities.
7. Ability to maintain a high degree of confidentiality.
8. Detail-oriented, customer- and quality-focused.
9. Excellent interpersonal and teamwork skills.
10. Computing skills in MS Office applications (preferred).
11. Proven flexibility and adaptability (preferred).

Benefits & Compensation

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance-based bonus.

Estimated Salary Range: $60,000 - $85,000.

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