Research Operations Coordinator

7 months ago

Vaughan, Canada SRX Health Solutions Inc Full time

Do you want to work with a collaborative, diverse team and gain innovative experience in one of the fastest evolving industries?_

SRx health solutions is a fast-growing healthcare solutions services company designed for today’s growing markets. We are Canada’s leading healthcare provider and have grown with over 400 employees across the country. We provide innovative, sustainable, and integrated healthcare solutions with a mission to enhance the wellness of Canadians. You will be part of a team that is dedicated to create immersive experiences and transforming ideas into successful health care programs that matter.

Here, you will be empowered to follow your passion to continuously learn and grow. Not to forget to mention, we have one of the friendliest teams on the globe

**Job Overview -**

The Research Operations Associate will work closely with the Study Start-up Specialist, Site Manager and Investigators to ensure regulatory and safety compliance.

**Regulatory & Ethics Coordination**:

- Prepare all site level ethics and regulatory submission forms (1572s, FDF, QIU, etc.) to Sponsor/Central IRBs during start-up phases.
- Independently work with IRB platforms ( Advarra, WCG, Veritas, etc.)
- Perform ethics review and submissions during and post study conduct, including but not limited to, SAEs,
- End of Study Notifications, Amendments, Continuing reviews

**Essential Document Management**:

- Responsible for document management for all current electronically maintained ISFs, including trailing paper-based studies in accordance with ICH-GCP Guidelines
- Maintain study trackers related to milestone and documents
- Adhere to all related compliance, safety and monitoring.

**Training & Site Qualification Oversight**:

- Collaborate with Sponsors and site staff, on the training and implementation of new protocols, consent forms, etc.
- Maintain full responsibility of research teams protocol specific training documentation.
- Track research non-study specific training/qualifications (i.e; GCP, Div5 certifications, CVs, Licenses, etc.) and maintain renewals in accordance with internal SOPs.
- Coordinate training of study teams/centers on all aspects of clinical study procedures (eg. SIV Scheudling, etc.)

**Study Operations support**:

- Coordinate site monitoring and site visits to confirm adherence to study protocol, procedures, ICH-GCP guidelines, local regulations.
- Work with various research platforms (SIP, Veeva Vault, iMedidata, IRT, CTMS etc.)
- Support study managers, in data entry, quality review, query handling, as needed.
- Support IP handling or shipment receipts, as needed.
- Support site management teams in audit preparation
- Provide coordination and direction in the development of site management practices for multiple studies.
- Prepare presentations for external and/or internal meetings, as needed

**Your Skills & Qualifications**:

- 3+ years of experience in clinical research
- Educational background in life sciences
- Previous ICH GCP training preferred
- Ensure compliance with the conduct of clinical trials.

**Why you should work with us?**
- Paid vacation
- Annual Bonus
- Paid sick days
- Comprehensive salary
- Benefits package
- RRSP
- Opportunities to develop new skills and progress your career

**_
If it sounds like you, we want you to apply_**

**About us**:

- SRx Health Solutions was founded in 2013 by its current President, Adesh Vora. After running retail pharmacies for over 12 years, Mr. Vora opened two pharmacies in Ontario. To achieve this, Mr. Vora recognized the need to provide more than just retail pharmacy services. Our company fosters a collaborative and inclusive work environment that empowers individuals to thrive, embrace challenges, and make a meaningful impact on the healthcare industry.

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