Clinical Research Assistant I

3 weeks ago

Markham, Canada Everest Clinical Research Full time

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 a committed, skilled, and customer-focused individual to join our winning team as a **Clinical Research Assistant **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**:

- Receive medical writing and safety monitoring projects and project information from the Direct Manager or from the Work Mentor for the assigned projects. The project information may include the study protocol, case report forms, Investigator’s Brochure, etc.
- Support medical writing and 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 submissions.
- 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.
- Collect, scan, and electronically assemble and publish clinical trial and regulatory documents.
- Assist with hardcopy and electronic archiving of clinical trial documents, including filing within a Trial Master File, according to established document control and archiving practices.
- Process, review, and assess 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.
- Write patient narratives for ongoing pharmacovigilance projects; includes review of patient data such as demographic, medical history, concomitant medication, and adverse event (AE) data in order to write a narrative that is up-to-date, complete and concise.
- Assist with reconciliation of safety data between clinical and safety databases.
- May act as a DMC/DSMB Secretary, producing meeting minutes and assisting the DMC/DSMB Administrator to plan, organize, and coordinate meetings and serve as the primary contact for day-to-day operations between the members and the Sponsor.
- Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
- 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**:

- At least two years' clinical trial experience in a pharmaceutical or CRO environment.
- Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical de

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