Pharma Medica Research (PMRI) Inc. is aContract Research Organizationthat strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people's lives. Come join our team!

We have an exciting opportunity for a full-time Clinical QC Associate within our PMRI clinic located in Scarborough, Ontario. In this role, you will 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 QC and/or designate.

Duties and Responsibilities

Responsibilities include but are not limited to:

• Prepare study source documents and/or forms in accordance with protocols, PMRI SOPs and regulations.

• Review and lock the electronic study setting in accordance with protocols.

• Review study tube arrangement for complicated study procedures based on risk assessment.

• 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 (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.

• Ensure that study files after study completion are accurate and legible according to protocols, PMRI SOPs, GCP requirements and regulations.

• Review other study or non-study related documents (e.g. pharmacy and equipment calibration records etc.).

• Provide reports on the observations/reviewed data to the relevant supervisors/managers and follow up upon resolution.

• Liaise with other departments to improve the accuracy and quality of data.

Minimum level of academic or formalized training:

• College degree or B.SC. in clinical research, health, or science-related field or equivalent.

Minimum amount of practical work experience:

• 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.

Other Requirements

• Good communication and interpersonal skills.

• Detail-oriented and good organizational skills.

• Strong proficiency in computer usage and software applications.

• Ability to work both independently and as a team member.

We offer:

• Competitive compensation plan

• Mentorship Opportunities

• A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution 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.