Quality Control Associate - CRO

Pharma Medica Research Inc.; Toronto; On-site; CAD 55,000 - 75,000; Full time

Job summary

A contract research organization is actively seeking a Clinical QC Associate I to ensure all study source documents comply with protocols and regulations. This role involves thorough reviews, observations of clinical procedures, and collaboration with various departments to enhance data integrity. Ideal candidates have a college degree in a related field, good knowledge of Phase I protocols and GCP, and strong organizational and communication skills. Attractive compensation and career progression opportunities are offered.

Benefits

Competitive compensation plan

Opportunities for advancement

Generous Employee Milestones Awards Program

Corporate Discounts Program

Learning Support Programs

Friendly atmosphere and culture of learning

Qualifications

• 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.

Responsibilities

• Prepare study source documents and/or forms in accordance with protocols and regulations.
• Review and lock the electronic study setting in accordance with protocols.
• Ensure study files are accurate and legible according to protocols.
• Liaise with other departments to improve data accuracy and quality.

Skills

Attention to detail

Communication skills

Interpersonal skills

Organizational skills

Computer skills

Education

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

Job description

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. 1. Prepare study source documents and/or forms in accordance with protocols, PMRI SOPs and regulations.
2. 2. Review and lock the electronic study setting in accordance with protocols.
3. 3. Review study tube arrangement for complicated study procedures based on risk assessment.
4. 4. Review study files upon data entry at the screening, check-in, on-study and post-study procedures.
5. 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. 6. Ensure that study files after study completion are accurate and legible according to protocols, PMRI SOPs, GCP requirements and regulations.
7. 7. Review other study or non-study related documents (e.g. pharmacy and equipment calibration records etc.).
8. 8. Provide reports on the observations/reviewed data to the relevant supervisors/managers and follow up upon resolution.
9. 9. Liaise with other departments to improve the accuracy and quality of data.
10. 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!