Clinical Research Safety Associate at Everest… · Markham

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 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.

Key Accountabilities:

1. Serve as the Data Monitoring Committee (DMC) Secretary and perform hands on administrative tasks for assigned projects, according to Everest’s SOPs. These tasks include, but are not limited to, the following:
   • 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.
2. 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 will involve planning, assessing, reporting, and tracking the progress status of the assigned projects, and monitoring the day-to-day operations of assigned projects to ensure goals and objectives are met, policies and procedures are being followed, and service is provided effectively and efficiently.
3. Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, with high quality and meeting regulatory requirements.
4. Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary
5. May support medical writing and clinical safety monitoring teams by performing quality control (QC) review of document deliverables.
6. Learn and perform document e-publishing for clinical trial and regulatory documents, including tables, listings, and graphs (TLGs), which may include collection, electronic assembly, bookmarking, hyperlinking of documents, and header/pagination stamping, etc. Ensure the final product meets specific document publishing requirements and timelines.
7. 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 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 and to manage multiple assignments with challenging/conflicting deadlines.
7. Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
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 when working in a team and independently, using good judgment in making decisions (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 http://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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