Quality Control Associate - CRO

Pharma Medica Research Inc.; Toronto; On-site; CAD 60,000 - 75,000; Full time

Job summary

A contract research organization in Toronto is seeking a Clinical QC Associate I to ensure compliance with protocols and regulations in clinical trials. This role involves preparing study documents, reviewing study files, and observing clinical procedures. Ideal candidates hold a relevant college degree and have strong organizational and communication skills. Join a friendly environment with opportunities for advancement and a competitive compensation plan.

Benefits

Competitive compensation plan

Opportunities for advancement

Employee Milestones Awards Program

Corporate Discounts Program

Learning Support Programs

Qualifications

• 1 year of CRO experience or equivalent is an asset.
• Good understanding of Phase I study protocols and conduct.
• Excellent computer skills.

Responsibilities

• Prepare study source documents in accordance with protocols and regulations.
• Review study files upon data entry.
• Observe clinical procedures during study conduct.

Skills

GCP requirements

Communication skills

Organizational skills

Detail-oriented

Education

College degree or B.Sc. in clinical research, health, or science-related field

Job description

Overview

Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We're currently searching for a Clinical QC Associate I to join our growing team!

The function of the Clinical QC Associate I is to ensure all prepared study source documents and/or forms of clinical activities are in accordance with the protocols, SOPs and regulations at Pharma Medica Research Inc. (PMRI). Review study files upon data entry at the screening, check-in, on-study, and post-study procedures. Observe, on a random basis, the clinical procedures during the conduct of studies and make sure that they are performed in accordance with protocols, PMRI SOPs, GCP requirements and regulations. Review study files after study completion and ensure the documentation is in accordance with protocols, PMRI SOPs, GCP requirement and regulations. This position reports to the Manager, Clinical QCand/or designate.

Duties and Responsibilities

1. Prepare study source documents and/or forms in accordance with protocols, PMRI SOPs and regulations.
2. Review and lock the electronic study setting in accordance with protocols.
3. Review study tube arrangement for complicated study procedures based on risk assessment.
4. Review study files upon data entry at the screening, check-in, on-study and post-study procedures.
5. Observe, on a random basis, the clinical procedures during the conduct of studies (i.e. screening procedures, subject entrance, meals, sample bundling, etc.), and make sure that they are performed in accordance with protocols, PMRI SOPs, GCP requirements and regulations.
6. Ensure that study files after study completion are accurate and legible according to protocols, PMRI SOPs, GCP requirements and regulations.
7. Review other study or non-study related documents (e.g. pharmacy and equipment calibration records etc.).
8. Provide reports on the observations/reviewed data to the relevant supervisors/managers and follow up upon resolution.
9. Liaise with other departments to improve the accuracy and quality of data.
10. Perform other assigned duties as required.

Qualifications

• College degree or B.SC. in clinical research, health, or science-related field or equivalent.
• At least 1 year of CRO experience or equivalent is an asset
• Good understanding of Phase I study protocols and conduct.
• Good knowledge of GCP requirements.
• Good communication and interpersonal skills.
• Detail-oriented and good organizational skills.
• Excellent computer skills.
• Ability to work both independently and as a team member.

We Offer

• Competitive compensation plan
• Opportunities for advancement and career progression
• A generous Employee Milestones Awards Program
• Corporate Discounts Program
• Learning Support Programs
• Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.

If you're looking for an exciting place to work with an incredible team, apply today!