Description
Syneos Health is seeking a Clinical Research Associate - Sponsor Dedicated - Bilingual (French/English). The successful candidate will be home-based in Quebec, Canada.
The Clinical Research Associate will perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key responsibilities include:
- Performing site qualification, site initiation, interim monitoring, site management, and close-out visits
- Evaluating overall performance of site and site staff and providing recommendations regarding site-specific actions
- Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Conducting Source Document Review of appropriate site source documents and medical records
- Applying query resolution techniques remotely and on-site, and providing guidance to site staff as necessary
- Utilizing available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifying site compliance with electronic data capture requirements
- Performing investigational product (IP) inventory, reconciliation, and reviews storage and security
- Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Documenting activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Supporting subject/patient recruitment, retention, and awareness strategies
- Entering data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution
- Understanding project scope, budgets, and timelines for own and others' activities in the clinical team
- Managing site-level activities/communication to ensure project objectives, deliverables, and timelines are met
- Acting as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
- Preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings
- Providing guidance at the site and project level towards audit readiness standards and supporting preparation for audit and required follow-up actions
- May provide training or mentorship to more junior level CRAs
The ideal candidate will have a strong understanding of ICH-GCP Guidelines, relevant regulations, and company SOPs/processes. They will also possess excellent communication and interpersonal skills, with the ability to work effectively with site staff, investigators, and project teams.
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.