Job Description

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 Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. 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:

• Bachelor degree in Clinical or Medical or Life Sciences with experience in the subject matter. M.Sc. preferred.

• 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 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.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.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. #LI-Remote
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