# Clinical Research Associate - Sponsor Dedicated - Bilingual (French/English)

**Company**: Syneos Health
**Location**: Quebec, QC
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CAN-Remote/Clinical-Research-Associate---Sponsor-Dedicated---Bilingual_25110765?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c242e791-29f

## 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.

## Skills

### Required
- ICH-GCP
- GCP
- Good Pharmacoepidemiology Practice (GPP)
- clinical research
- site management
- regulatory compliance
- French
- English

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CAN-Remote/Clinical-Research-Associate---Sponsor-Dedicated---Bilingual_25110765?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)