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Clinical Study Associate (CSA)

Alio Health

This is a Full-time position in Montréal, QC posted January 12, 2018.

Allphase Clinical Research Inc. (an affiliation with Alio Health Services) requires a Clinical Study Associate to work within our dynamic Clinical Operations team. The Clinical Study Associate (CSA) is an integral part of the study team, responsible for the creation, distribution and quality assurance of study materials, tools and documents. The CSA ensures these activities are conducted in accordance with the Client and Allphase protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and all applicable regulatory requirements. The position supports Clinical Operations by tracking and reporting study metrics as well as by performing in-house management activities to ensure efficient and effective study conduct and to drive projects forward to completion in accordance with contract and client expectations.

Responsibilities:

  • Identify and evaluate potential clinical study sites for study feasibility.
  • Assist with site contract preparation and distribution.
  • Prepare, distribute, collect and review all essential study related documentation from sites for accuracy and completeness.
  • Ensure client and investigator documentation obligations are being met and are in compliance with applicable regulatory requirements, client SOPs and ICH-GCP guidelines.
  • Liaise with sites to update and correct information in a timely fashion.
  • Set-Up, Maintain and Archive study files (electronic as well as physical Trial Master Files).
  • Perform and track ethics submissionsPrepare study binders and distribute study tools.
  • Attend study team meetings as required, write meeting minutes and prepare any study progress reports.
  • Create and maintain any study specific tracking databases, as required.
  • Act as the main contact for both internal and external study team members and identify and resolve problems at clinical study sites.
  • Work collaboratively with members of the study team to problem solve and promote progress.
  • Prepare site payments and track payment activities.
  • Quality Control of documents and medical supplies.
  • Customer Service interaction with home health care nurses, patients and program coordinators.
  • Prepare and send daily courier shipments.
  • Assist the Clinical Study Manager in any functions as required.
  • Fulfill other duties as required.

 

Competencies:

  • Undergraduate degree in Science or Nursing, or equivalent work experience.
  • Minimum of 2 years of clinical research experience.
  • Self-motivated and proactiveTeam player with initiative to learn and handle multiple assignments independently.
  • Ability to act as a liaison with vendors and other functional team members to meet project goals.
  • Ability to prioritize and manage multiple projects concurrently.
  • Excellent organizational skills and attention to detail.
  • Above average problem solving skills.
  • Strong interpersonal and customer service skills to promote effective working relationships with others.
  • Ability to maintain composure and function effectively under pressure.
  • Strives to streamline and improve processes supporting clinical operations and the business.
  • Ability to organize, create and present study data in order to support metrics and business activities.
  • Proficiency using computerized systems, Microsoft Office Applications, including electronic spreadsheets is required.
  • Excellent English communication skills (verbal and written) mandatory, and French is an asset.

Skills Required

  • Education level: University
  • Work experience (years): 3-5 years

Package

Salary: N/D

How to Apply