Senior Clinical Research Associate Job at System One, Canada

OGlycEhlRmRmWlYyTlZUL0FtTmtqa3RueHc9PQ==
  • System One
  • Canada

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,

Similar Jobs

Reyes Beverage Group

Beer Stocker Job at Reyes Beverage Group

 ...Position Summary: Our Merchandising Team supports our Sales & Delivery Departments by ensuring our products are up to date, our brands...  ...out in top retailers nationwide. Merchandisers travel to grocery stores to ensure products are stocked, maintained, displayed, and... 

Home Depot / THD

Principal Data Scientist - Recommendations, Online Data Science Job at Home Depot / THD

 ...customer experience. This role assists in the development of the Home Depot advanced analytics infrastructure that informs decision making...  ...with Google BigQuery or SQL).Advanced knowledge of Microsoft Office Suite.Expertise with data visualization software (preferably... 

I Am Boundless, Inc.

Compliance Officer Job at I Am Boundless, Inc.

 ...Job Description Job Description Summary/Objective The Compliance Officer is a director-level position responsible for overseeing and managing the compliance function across the organization, ensuring adherence to legal and regulatory requirements, promoting ethical... 

Chronos Consulting

VP Sales, Enterprise Software Startup San Francisco Job at Chronos Consulting

VP Sales, Enterprise Software Startup San Francisco Our client is an emerging leader in the field of web accessibility. They are looking for an experienced, driven VP of Sales to build and lead their North American sales operation. If you are interested and fit the below... 

SynergisticIT

Python/R Developer (Remote) Job at SynergisticIT

 ...the clients with candidates who have the requisite skills and experience to outperform at interviews and clients. Here at SynergisticIT...  ...software development life cycleKnowledge of Statistics, SAS, Python, Computer Vision, data visualization toolsExcellent written and...