Clinical Research Coordinator

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 rapidly expanding provider of healthcare solutions tailored for contemporary markets. As a leading healthcare entity in Canada, we have expanded to over 400 employees nationwide. Our mission is to deliver innovative, sustainable, and integrated healthcare solutions that enhance the well-being of Canadians. You will be part of a dedicated team focused on creating impactful experiences and transforming concepts into successful healthcare initiatives.

At SRx Health Solutions, you will have the opportunity to pursue your passion for continuous learning and professional growth. Our team is known for its friendly and supportive environment.

Role Overview

The Clinical Study Coordinator (CSC) is tasked with overseeing the daily operational elements of both new and ongoing industry-sponsored clinical trials. Reporting directly to the Clinical Site Manager, the CSC plays a crucial role in facilitating the efficient initiation, execution, and conclusion of multiple clinical trials, ensuring compliance with Health Canada Division 5, US-FDA, ICH-GCP, local regulations, and company policies. We are seeking an enthusiastic individual to take on the Clinical Study Coordinator role. As a vital member of the team, candidates should possess knowledge of clinical trial processes, regulations, and best practices, and be capable of independently addressing a variety of routine challenges with guidance as needed. The CSC collaborates with Study Managers, Investigators, and healthcare teams to assist in the coordination of patient recruitment in accordance with regulatory and company standards for our diverse clinical trials. The CSC will also share responsibility for the initial and ongoing upkeep of all study-related procedures and documentation concerning study participants.

Key Responsibilities
  • Assist the Study Manager in fulfilling study-related obligations, including conducting patient visits and managing study supplies.
  • Recruit study participants by identifying and screening potential subjects and obtaining informed consent.
  • Coordinate patient visit schedules in alignment with study protocols.
  • Acquire the necessary technical knowledge of assigned studies and accurately execute and coordinate the operational demands of such studies as outlined in the Protocol.
  • Participate in Sponsor Investigator meetings as required.
  • Attend site initiation meetings for assigned studies.
  • Consult with investigators as necessary.
  • Document all required subject study data in source worksheets or eSource during study visits and maintain subject study files.
  • Collect, process, and ship blood samples and other biological specimens from study participants.
  • Review study-related laboratory results and flag any out-of-range data for Investigator review.
  • Ensure that study data is entered into the Electronic Data Capture (EDC) portal within 3-5 working days of study visits or as otherwise required by the Sponsor.
  • Collaborate with the Clinical Study Manager to review and resolve Sponsor-initiated data queries.
  • Report Adverse Events, Serious Adverse Events, and Protocol Deviations in accordance with REB, sponsor, and Health Canada guidelines.
  • Inform the Principal Investigator, Sub-Investigator, and clinical study team of all Adverse Events (AE)/Serious Adverse Events (SAE) occurring at the site for review and timely reporting.
  • Manage the dispensation, administration, collection, and accountability of Investigational Products.
  • Assist in maintaining the Investigator Site File and regulatory affairs.
  • Support the Investigator with any endoscopic requirements of a protocol, as applicable.
  • Address other SRx Health Solutions-related tasks and processes as necessary.
  • Adhere to GCP and confidentiality requirements, SRx SOPs, and generally accepted medical and business practices.
Qualifications
  • Diploma in Registered Practical Nursing or a recognized equivalent in a health or science-related field.
  • Two (2) years of clinical research experience is preferred.
  • Registered Practical Nurse with a minimum of two (2) years of experience is preferred.
  • Current registration with the College of Nurses of Ontario.
  • Knowledge of IATA shipping regulations and basic laboratory procedures is advantageous.
  • Certification in clinical research (ACRP, CCRP, or SOCRA) is desired.
  • Demonstrated ability to utilize the nursing process in planning, implementing, and evaluating patient care.
  • Evidence of strong physical assessment and patient education skills.
  • Autonomous clinical critical thinking skills.
  • Current training in ICH-GCP guidelines is preferred.
  • Excellent organizational and time management skills are essential.
  • Strong attention to detail with the ability to manage multiple responsibilities effectively.
  • Robust analytical and problem-solving skills.
  • Exceptional interpersonal, verbal, and written communication skills are required.
  • Ability to prioritize tasks and work independently as well as collaboratively in a dynamic environment.
  • Willingness to work at all SRx Specialty Research Locations.
  • Experience with parenteral injections (IV, SC, IM) is desired.
  • Knowledge of reconstitution and administration of medications is preferred.
  • Ability to perform electrocardiograms (ECG).
  • Current BCLS certification is required.
  • A thorough understanding of the ALCOA principles is essential.
Benefits of Working with Us
  • Paid vacation.
  • Annual bonus opportunities.
  • Paid sick leave.
  • Comprehensive salary package.
  • Benefits program.
  • RRSP contributions.
  • Opportunities for skill development and career advancement.

About SRx Health Solutions

Founded in 2013 by President Adesh Vora, SRx Health Solutions has evolved from operating retail pharmacies to providing comprehensive healthcare services. Our company promotes a collaborative and inclusive work culture that empowers individuals to excel, embrace challenges, and make a significant impact in the healthcare sector.

Diversity and Inclusion Commitment

SRx Health Solutions is dedicated to fostering a workplace environment that values diversity and inclusion, ensuring that all employees feel valued and heard. We embrace a diverse representation of gender, race, thought, and other personal characteristics that enhance our business and community. We also provide accommodations during the interview process.

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