Clinical Research Safety Associate

Overview

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. Everest serves a diverse client base and works with many 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, and has evolved into a full-service CRO.

The 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 for high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. The organization is dynamic with an entrepreneurial origin and continues to experience growth and success.

Quality is our backbone, customer-focus is our tradition, and flexibility is our strength.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Research 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.

• Serve as the DMC Secretary and perform hands-on administrative tasks for assigned projects, according to Everest’s SOPs. These tasks include, but are not limited to:
• Assist with identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments.
• Serve as the liaison between the committee and the sponsor.
• Write the committee Charter and its amendments, circulate for review, finalization, and sign-off by the committee and Sponsor.
• Assist with coordinating the preparation of the committee Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the committee members, according to the Charter.
• Plan, schedule, and coordinate all committee meetings, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter, according to the Charter.
• Support project management of DMC area with activities focused on planning and execution of DMC administration tasks and biostatistical support for these committees for assigned projects. This role involves planning, assessing, reporting, and tracking progress, and monitoring day-to-day operations to ensure goals are met and services are provided effectively.
• Manage planning, implementation, conduct, and reporting of assigned projects within established timelines and budgets, with high quality and regulatory compliance.
• Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary.
• Support medical writing and clinical safety monitoring teams by performing quality control (QC) review of deliverables, including CSR, study protocols, informed consent forms, patient safety narratives, safety management plans, scientific publications, and other regulatory documents.
• Under supervision, perform medical writing tasks such as simple clinical study reports, simple study protocols, and other regulatory documents.
• Perform data verification (QC) on statistical programming outputs against source data (e.g., patient case report forms) and report discrepancies found during QC.
• Perform consistency review of document formats, styles, and layout according to a document style guide.
• Learn and perform document e-publishing for clinical trial and regulatory documents, including CSRs and tables, listings, and graphs (TLGs), ensuring final products meet publishing requirements and timelines.
• May assist with case processing of safety events (SAE and/or pregnancy reports) from ongoing trials, including review of reports, data entry into safety databases, generating queries, and QC of safety data.
• May assist with reconciliation of safety data between clinical and safety databases.
• Keep current on Everest Guidance Documents and on regulatory requirements or guidelines issued by pharmaceutical drug trial regulators and ICH.

• M.Sc. or Ph.D. in a clinical, medical, or health-related field.
• At least two years of clinical research experience in an academic, pharmaceutical, or CRO environment.
• Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards.
• Experience with an accepted clinical data capture and management system (preferred).
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
• Good organizational skills with the ability to adapt to changing priorities and manage multiple…