We are seeking experienced Clinical Research Associates (CRAs) to lead and support a Full Service Outsourcing team overseeing clinical trials, with a focus on Oncology or Ophthalmology. Bilingual (French-English) candidates and CAR-T experienced Sr. CRAs are highly desirable. This role involves conducting 8-10 site visits per month across Canada, including travel support.
Key responsibilities include:
- Monitoring all aspects of study sites, including routine visits, site close-outs, study file maintenance, and vendor liaison.
- Managing site activities per project plans, ensuring protocol adherence, patient safety, and data integrity.
- Verifying informed consent and regulatory compliance, reviewing source documents, and managing registry tasks.
- Handling Serious Adverse Event (SAE) reporting, performing CRF reviews, and resolving data queries.
- Training new staff, coordinating clinical projects as a Local Project Coordinator, and supporting other duties as assigned.
Qualifications include:
- University or college degree or relevant health professional certification.
- 1-3+ years of clinical monitoring experience, preferably in Oncology or Ophthalmology.
- Open to candidates across various Canadian hubs; French language skills preferred.
The role requires:
- Ability to work in a fast-paced, dynamic environment with changing priorities.
- Strong teamwork, communication, and technological skills, with proficiency in electronic data collection.
- Physical capability for extended sitting, occasional travel, and light lifting.
- Consistent attendance and adaptability to varied working hours.