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Senior Clinical Research Specialist
3 weeks ago
We are looking for a highly skilled and experienced Clinical Research Associate Lead to join our team in Toronto. As a key member of our team, you will be responsible for overseeing multiple oncology trials, providing leadership and mentorship to junior colleagues, and ensuring high-quality execution of these trials.
In this role, you will have the opportunity to develop essential study start-up documents, including SIV agendas, and represent Site Managers and Lead Trial Managers in key meetings. You will also ensure that the SM perspective is reflected in study documents like Monitoring Guidelines and review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial.
Key Qualifications:
- A minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
- At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
- Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
- Knowledge of risk-based/analytical monitoring approaches is an asset
- Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
- Ability to actively drive patient recruitment strategies at assigned sites
- Strong collaboration with investigators and site staff to meet study timelines
- Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
- Ability to work independently while being a strong collaborator
- In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
- Up to 50% regional travel required
About Us:
Pharmaceutical Research Associates, Inc. is a leading clinical research organization committed to advancing medical innovation through high-quality clinical trials.
