Quality Control Associate - CRO

at  Pharma Medica Research Inc

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 QC and/or designate.

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.

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.