Senior Clinical Research Associate - Joulé

Skills

Data Analysis

Job Specifications

Title: Senior Clinical Research Associate
Location: Home Based - Montreal, Quebec Canada
Type: Direct - Long term/Salaried contract
Start Date: August/September 2025
Leading Pharmaceutical Company located in Montreal is hiring a Medical Affairs Project Coordinator 3+ years industry experience. If you want to be a part of this groundbreaking work, please apply!
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
Comfortable with Montreal-based travel and across the Quebec province
MUST be Bilingual French/English
Cardiovascular experience is preferred/a nice to have
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

- YG1
Ref: #568-Clinical

About the Company

At Joule, we believe our world is filled with possibilities - where character, integrity, and commitment drive our purpose. For over 30 years, Joule has been a trusted partner to industry-leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joule's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joule is a System One division. Know more