Senior Clinical Research Associate

System One; Calgary; Remote; CAD 80,000 - 120,000; Full time

Job summary

A leading workforce solutions provider is seeking a Senior Clinical Research Associate for a remote position based in Calgary or Edmonton, Alberta. The ideal candidate will have over 4 years of CRA monitoring experience and must be agreeable to travel across Western provinces. Responsibilities include site management, ensuring data quality, and compliance with trial protocols. Excellent communication and critical thinking skills are essential for this role.

Benefits

Health and welfare benefits

401(k) plan

Qualifications

• 4+ years of CRA experience, ideally 5+ years in field CRA monitoring for drug trials.
• 6+ years of clinical research industry experience.
• Experience working with institution sites is a plus.

Responsibilities

• Provide site management and support from trial initiation to closeout.
• Ensure collection of high-quality data and protocol compliance.
• Train external trial staff regarding data entry and reporting.

Skills

Critical thinking

Remote Monitoring Experience

Risk Based Monitoring

Flexible and agile

Excellent communication

Education

BA/BS or higher

Tools

EDC – Inform

CTMS – Impact

Job description

Job Title: Senior Clinical Research Associate
Location: Calgary, Alberta

Type: SALARIED
Contractor Work Model: Remote

• Quantity of positions: 1
• Location: Home-basedin 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 fordrug 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