CROMSOURCE

Clinical Research Associate, Canada - L

Company
CROMSOURCE
Location
Canada
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
HQ00002349
Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Description:
Location: British Columbia, Calgary or Toronto, Canada

Schedule: Freelance - 0.25 FTE

Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, are looking for a dynamic person to join our in-house team. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.

As Clinical Research Associate, you will be responsible for full site-management from feasibility to close-out of studies.

Main Job Tasks and Responsibilities:
  • Assist in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigational sites.
  • Perform training of site staff in all study procedures in order to ensure protocol/ICH-GCP compliance
  • Conduct and report periodic monitoring visits in the field and review at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's, ICH-GCP requirements in order to ensure data integrity and subject safety.
  • Adapt and translate Patient Information Leaflets and Informed Consent Forms.
  • Cooperate with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reactions such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues.
  • Escalates any issues to relevant project team members.
  • May assist in contract negotiation with sites on study budget after appropriate and documented training.
  • May support the submission process in the project (or region).


Education and Experience:
  • University Degree in scientific, medical or paramedical discipline.
  • Prior experience as a CRA.


Specific Role Requirements and Skills:
  • Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements.
  • Fluent in English and French.
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
  • Willingness to travel.


The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website https://www.cromsource.com/careers/job-vacancies/job-information/?job-id=HQ00002349

please contact laura.guascone@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Key words: CRA, Clinical Research Associate, Monitor, Clinical Research, CRO, Contract Research Organisation, Clinical Trials, Clinical, Submissions, ICH-GCP, Monitoring
Skills: Clinical Research Associate, Senior Clinical Research Associate Location: Canada Share:

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