Clinical Research Safety Associate

4 weeks ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

About the Role:

We are seeking a highly skilled and customer-focused individual to join our team as a Clinical Research Safety Associate at Everest Clinical Research Services Inc. in Toronto/Markham, Ontario, Canada, or remotely from a home-based office anywhere in Canada.

Key Responsibilities:

  • 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, writing the committee Charter and its amendments, and circulating for review, finalization, and sign-off by the committee and Sponsor.
  • Coordinate the preparation of the committee Data Reports by external or internal statistical programming teams and deliver 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, 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 purposes.
  • 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, and 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, including reviewing hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports, entering case safety data into the safety database, 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, and 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.

Requirements and 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).

About Us:

Everest Clinical Research Services Inc. 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.

We have been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, we have successfully developed and established ourselves as a full-service CRO. Our 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.

We are known in the industry for our high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, we continue to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength. We are committed to delivering exceptional results and building long-term relationships with our clients.

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