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 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 :

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, 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.

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.

• 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, including clinical study reports (CSR), clinical study protocols, informed consent forms, patient safety narratives, safety management plans, scientific publications, and other documents intended for regulatory
• Under supervision, perform medical writing tasks, including but not limited to, writing of the following documents : simple clinical study reports, simple study protocol, and other regulatory documents.
• Perform data verification (QC) on statistical programming outputs against data source such as patient case report forms or other information provided.

Report discrepancies found during the QC procedure.

• 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, including CSRs and tables, listings, and graphs (TLGs), which may include collection, scanning, electronic assembly, bookmarking, hyperlinking of documents, document cleaning, and header / pagination stamping, etc.

Ensure the final product meets specific document publishing requirements and timelines.

May assist with case processing of safety events (SAE and / or pregnancy reports) from clients’ ongoing drug 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 safety data into the safety database and generating queries for any critical or missing information.Interacting with the Lead Safety Associate 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 entered by another Safety Associate.

• May assist with reconciliation of safety data between clinical and safety databases.
• 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 :

• 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).
Il y a 25 jours