Clinical Trials Operations Specialist

4 weeks ago

Vaughan, Ontario, Canada SRx Health Solutions Full time

Are you interested in contributing to a dynamic and diverse team while gaining valuable experience in a rapidly advancing sector?

SRx Health Solutions is a leading provider of healthcare solutions in Canada, dedicated to delivering innovative and sustainable services tailored to meet the needs of today’s evolving markets. With a workforce of over 400 professionals nationwide, we are committed to enhancing the health and wellness of Canadians through integrated healthcare solutions.

Role Overview

The Clinical Study Coordinator (CSC) plays a pivotal role in managing the daily operational aspects of both new and ongoing clinical trials sponsored by industry partners. Reporting directly to the Clinical Site Manager, the CSC is instrumental in ensuring the efficient initiation, execution, and closure of multiple clinical trials, adhering to the standards set by Health Canada Division 5, US-FDA, ICH-GCP, and internal policies.

Key Responsibilities

  • Assist the Study Manager in fulfilling study-related tasks, including conducting patient visits and managing study supplies.
  • Engage in the recruitment of study participants by identifying and screening potential subjects and obtaining informed consent.
  • Coordinate patient visit schedules in accordance with study protocols.
  • Acquire the necessary technical knowledge of assigned studies and effectively execute operational requirements as dictated by the study protocol.
  • Participate in Sponsor Investigator meetings as needed.
  • Attend site initiation meetings for assigned studies.
  • Consult with investigators as required.
  • Document all necessary subject study data during visits and maintain accurate subject study files.
  • Collect, process, and ship biological specimens from study participants.
  • Review study-related laboratory results and highlight any out-of-range data for investigator assessment.
  • Ensure timely entry of study data into the Electronic Data Capture (EDC) portal.
  • Collaborate with the Clinical Study Manager to address and resolve data queries initiated by the Sponsor.
  • Report adverse events and protocol deviations in accordance with regulatory guidelines.
  • Maintain the Investigator Site File and assist with regulatory affairs as needed.
  • Adhere to Good Clinical Practice (GCP) and confidentiality standards.

Qualifications

  • Diploma in Registered Practical Nursing or an equivalent qualification in a health or science-related field.
  • A minimum of two years of clinical research experience is preferred.
  • Current registration with the College of Nurses of Ontario.
  • Familiarity with IATA shipping regulations and laboratory procedures is advantageous.
  • Certification in clinical research (ACRP, CCRP, or SOCRA) is desired.
  • Strong organizational, analytical, and problem-solving skills.
  • Excellent communication skills, both verbal and written.
  • Ability to prioritize tasks and work independently as well as collaboratively in a team environment.

Why Consider a Career with Us?

  • Competitive salary and comprehensive benefits package.
  • Paid vacation and sick days.
  • Annual bonus opportunities.
  • Support for professional development and skill enhancement.

About SRx Health Solutions

Founded in 2013, SRx Health Solutions has established itself as a key player in the healthcare industry, driven by a commitment to diversity and inclusion. Our work environment encourages individuals to thrive, face challenges, and make a significant impact in healthcare.

SRx Health Solutions values diversity and strives to create an inclusive atmosphere where all employees feel respected and heard.

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