Clinical Research Associate
2 weeks ago
CMX Research Inc (CMX) is a full-service CRO (Contract Research Organization) providing clinical trial management services and monitoring for investigational drugs and devices. We manage First-in-Human, Phase I, II, IV as well as Observational Studies and Registries of Marketed Drugs providing Real-World Data. We are located in Oakville, Ontario have been in business since 1996.
We are a niche CRO specializing in Urology and Uro-Oncology trials. CMX also monitors BA/BE studies, Phase I and IIb in various indications. What makes CMX special is, we are a tight-knit family-like organization that has close relationships with the principal investigators and study coordinators at the CMX network sites. We are a compact company with a flat organizational chart. All employees report to the Managing Director.
CMX requires a Clinical Research Associate (CRA) to monitor CMX managed trials as well as our contracted monitoring projects. We are looking for someone who is committed, loyal and wants a work-life balance.
The CRA role includes but is not limited to:
- Monitor studies within ICH-GCP regulatory requirements
- Monitor BA/BE studies at Phase I units in Toronto, ON and Montreal, QC
- Conduct site visits including SSV, SIV, IMV, COVs
- Manage queries, database lock, TMF in a timely manner
- Ensure proper SAE reporting according to project and regulatory requirements
- Assist patient eligibility, monitor compliance, and collaborate with site medical staff
- Facilitate use of the protocol as well as maintain quality assurance through accurate and timely data reporting
- Attend the CMX office 1-2 times a week. Work-from-home is acceptable
- Assist in coordinating clinical trial research studies including multi-centre Phase I, II, IV trials
- Assist in preparation of protocols for scientific and ethical review
- Assist in creating source documents, CRFs, patient diaries, drug labelling
- Participate in educational initiatives regarding clinical trials (SOCRA, CRAC, etc)
- Travel is required (35%-40%)
- French speaking would be an asset
Schedule:
- Monday to Friday
Work Location: Hybrid remote in OAKVILLE, ON
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