Senior Clinical Research Associate

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 prevent or mitigate them.
• 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.