Senior Clinical Research Associate Job at System One, Caledonia, WI

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  • System One
  • Caledonia, WI

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, Work from home, Home office, Flexible hours, 1 day per week,

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