Job Description
Job Title: Senior Clinical Research Associate
Location: Calgary, Alberta
Type: SALARIED
Contractor Work Model: Remote
- Quantity of positions: 1
- Location: Home-based in Calgary or Edmonton, Alberta
- Must be agreeable to travel across Western provinces (BC, AB, MB, SK)
- Start date is ASAP Title: Senior Clinical Research Associate
Location: Home Based - Calgary or Edmonton, Alberta
Type: Direct - Long term/Salaried contract
MUST HAVES - Educational requirement: BA/BS or higher, required
- Years of experience: 4+ years of CRA (monitoring experience from sponsor or CRO) - ideally looking for 5+ years of field CRA monitoring experience for drug trials
- Industry experience: 6+ years of clinical research industry experience
- Experience working with institution sites is a plus
- Must be able to work well independently and have strong critical thinking skills
- Remote Monitoring Experience
- Risk Based Monitoring experience
- Complex trial experience is a preferred
- Flexible, agile, excellent communication and able to learn new systems/is technically savvy
RESPONSIBILITIES
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 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
SYSTEMS
EDC – Inform
CTMS – Impact
EQUIPMENT PROVIDED
-Laptop with docking station
-Printer
-Monitor
-Keyboard and mouse
-Cellphone (includes Hotspot for wireless connection)
-iPad
System One, and its subsidiaries including Joulé, ALTA IT Services, 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.
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Ref: #568-Clinical
Job Tags
Contract work, For contractors, Long term contract, Local area, Immediate start, Remote work, Work from home, Home office, Flexible hours, 1 day per week,