Clinical Study Coordinator

1 month 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

**We are hiring for multiple positions**

**About the role**:
**SPECIFIC DUTIES AND RESPONSIBILITIES**:

- Supports Study Manger in conducting study-related requirements, including performing patient visits and maintenance of study supplies.
- Coordinating patient visit schedules as per study protocol.
- Obtains the required technical knowledge of assigned studies and accurately executes and coordinates the operational requirements of such studies as mandated by the Protocol.
- Attends Sponsor Investigator meetings as required.
- Attends TDDA site initiation meetings for assigned studies.
- Consulting with the investigators as required.
- Reviews study-related laboratory results and flags out-of-range data for Investigator review/signing.
- Ensures that study data is entered in the Electronic Data Capture (EDC) portal within 3-5 working days of study visits or as otherwise mandated by the Sponsor.
- Collaborates with Clinical Study Manager to review and resolve Sponsor-initiated data queries.
- Reporting Adverse events, Serious Adverse events and Protocol Deviations according to REB, sponsor and Health Canada guidelines
- Reports to the Principal Investigator, Sub-Investigator and clinical study team all Adverse Events (AE)/Serious Adverse Events (SAE) experienced at the site for review, assessment and timely reporting.
- Responsible for Investigation Product dispensation, administration, collection and accountability.
- Assists with maintenance of Investigator Site File and regulatory affairs.
- Assists Investigator with the endoscopic requirements of a protocol, as applicable.
- Resolves other TDDA related items and/or processes which may arise, and which are considered appropriate.
- Must adhere to GCP and confidentiality requirements, TDDA SOP’s, and generally accepted medical and business practices and requirements.

**REQUIREMENTS**:

- Diploma in Registered Practical Nursing, or recognized equivalent, in a health or science-related discipline.
- One (2) years clinical research experience desired.
- Registered Practical Nurse with a minimum of two (2) year’s experience preferred.
- Current registration with the College of Nurses of Ontario.
- Knowledge of IATA shipping regulations and basic laboratory procedures an asset.
- Recognized certification in clinical research (ACRP, CCRP or SOCRA) desired.
- Demonstrated knowledge and ability to utilize the nursing process in planning, implementing and evaluating patient care.
- Evidence of good physical assessment and patient teaching skills.
- Autonomous clinical critical thinking ability.
- Current Training in ICH-GCP guidelines desired.
- Excellent organizational and time management skills required.
- Demonstrates strong attention to detail with the capacity to manage multiple responsibilities in a timely manner
- Strong analytical and problem-solving skills.
- Excellent interpersonal, verbal and written communication skills required.
- Ability to set priorities and work independently and as a team member with accuracy in a dynamic environment.
- Expected to work at all TDDA Specialty Research Locations.
- Experience with the parenteral injections (IV,SC,IM) desired.
- Reconstitution of administration of medications desired.
- Possess the knowledge required to perform and electrocardiograph (ECG)
- Current BCLS certification
- A thorough understanding of the ALCOA principles.

**Qualifications**:

- **Diploma in Registered Practical Nursing**:

- Current registration with the College of Nurses of Ontario
- Registered Practical Nurse with 2 years Clinical Research experience
- Sound understanding of ethical standards, ICH/GCP guidelines, HC division 5, IATA certificate desired
- Recognized certification in clinical research desired.

**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.

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