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 to join our growing team!
The Clinical QC Associate ensures all prepared study source documents and / or forms of clinical activities are in accordance to protocols, SOPs and regulations at Pharma Medica Research Inc.
PMRI ). Assist in the review of study files upon data entry at the check-in, on-study and post-study procedures. Observe randomly the clinical procedures during the conduct of studies and make sure that they are performed in accordance to protocols, PMRI SOPs, GCP and regulations.
Review study files after study completion and ensure the documentation is in accordance to protocols, PMRI SOPs, GCP and regulations.
This position reports to the Manager, Clinical QC and / or designate.
Duties and Responsibilities :
- Ensure all prepared study source documents and / or forms are in accordance to protocols, PMRI SOPs and regulations.
- Assist in the review of study files upon data entry at the 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 to protocols, PMRI SOPs, GCP and regulations (i.
e. screening procedures, subject entrance, meals, sample bundling, etc.).
- Ensure that study files after study completion are accurate and legible according to protocols, PMRI SOPs, GCP and regulations.
- Assist in the review of other study related documentation (i.e. pharmacy records).
- Provide reports on the observations / reviewed data to the relevant supervisors / managers and follow-up upon resolution.
- Interacts with other departments to improve the accuracy and quality of data.
- Perform other assigned duties as assigned.
Qualifications :
- Graduate degree, B.Sc. in Health Sciences or equivalent
- 2 years CRO experience or equivalent
- Excellent understanding of Phase I study protocols and conduct
- Good knowledge of SOPs and GCP requirement
- Strong interpersonal, organizational, and communication skills
- Ability to work both independently and as a team member
- Computer software knowledge
If you're interested in this exciting position, apply today!
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