System One Looking for Senior Clinical Research Associate at Vancouver, British Columbia, Canada Full Time

Location: Vancouver, BC

Hours/Schedule: M-F, 8 am – 5 PM

Overview

KEY AREAS OF RESPONSIBILITY

Site Management

• 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 take action 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.

Other

• Adheres to Company policies, procedures ,vision and fundamentals
• Acts as back up to the other monitors during absences, as requested
• Performs other tasks as assigned by management

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

Requirements

• Educational requirement: BA/BS
• Years of experience: 5+ years of CRA (monitoring experience)
• Industry experience: 7+ years of clinical research industry experience
• Remote Monitoring Experience

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer 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.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.