Job Description
Senior Clinical Research Associate - Regional Location: Home Based, Toronto, Ontario, or Montreal, Quebec, Canada Type: Direct - Long term/Salaried contract
Start Date: ASAP
Are you an experienced Clinical Research Associate that's looking for lower, regional travel and a good work/life balance? Do you value a healthy, and engaging work environment?
This is an excellent opportunity to check off all of the above!
You are working for a sponsor, in a therapeutically aligned model supporting Endocrinology studies, conducting remote and onsite monitoring of regional sites in a risk-based monitoring model.
Responsibilities: - Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout
- Ensure collection of high-quality data, timely adverse event reporting, subject protection and compliance to the protocol
- Adherence to ICH-GCP, Canadian regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines
- Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met
- Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones
- Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing
- Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.
- Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines
- Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables.
- Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
- Identify potential risks and proactively to prevent or mitigate
- Participates in Sponsor and Regulatory audits in Canada; preparing external trial staff and site records, addressing questions from Auditor, supporting external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, Company SOPs and ICH-GCP.
Requirements: - Educational requirement: BA/BS
- Years of experience: 4+ years of CRA (monitoring experience) - ideally looking for 5+ years of field CRA monitoring experience for drug trials
- Industry experience: 6+ years of clinical research industry experience
- Diabetes experience is a nice to have
- Remote Monitoring Experience
- Risk Based Monitoring experience
- Flexible and agile
- Comfortable with travel from Newfoundland to Saskatchewan
- Complex trial experience
- Bilingual French/English
Working Conditions: - Works from a home office environment at least one day a week.
- Works at hospitals, medical clinics three to four times a week.
- May be required to drive, fly, or take train to location to perform duties of the job.
- Up to 70% travel required.
Benefits: System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
Job Tags
Contract work, Local area, Immediate start, Remote job, Home office, Flexible hours, 1 day per week,