[Hiring] Clinical Research Safety Associate @Everest Clinical Research

Role Description

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.
• Assist with the 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 and circulate for their 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.
• Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, with high quality and meeting regulatory requirements.
• 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 document deliverables.
• Under supervision, perform medical writing tasks, including writing of simple clinical study reports, simple study protocol, and other regulatory documents.
• Perform data verification (QC) on statistical programming outputs against data sources.
• Perform consistency review of document formats, styles, and overall layout according to a document style guide.
• Learn and perform document e-publishing for clinical trial and regulatory documents.
• May assist with case processing of safety events (SAE and/or pregnancy reports) from clients’ ongoing drug clinical trials.
• Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.

Qualifications

• M.Sc. or Ph.D. in a clinical or medical or health-related field.
• At least two years' 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 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 (preferred).
• Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions (preferred).

Benefits

• Robust benefits package including medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.
• Estimated Salary Range: $60,000 - $85,000.