Senior Clinical Research Associate

System One; Quebec; Remote; CAD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Associate to join their dynamic team. This role offers the chance to work in a flexible environment with a strong focus on work-life balance. You will be responsible for managing clinical trial sites, ensuring high-quality data collection, and adhering to regulatory standards. With opportunities for remote work and minimal travel, this position is perfect for those looking to make a significant impact in clinical research while enjoying a collaborative and supportive atmosphere. Join a forward-thinking company that values your expertise and fosters professional growth.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Life Insurance

Qualifications

• 4+ years of CRA monitoring experience, ideally in drug trials.
• Bilingual in French and English is preferred.

Responsibilities

• Provide site management and support from trial initiation to closeout.
• Ensure compliance with ICH-GCP and local regulations.
• Prepare and complete monitoring visit reports and follow-ups.

Skills

Clinical Research Monitoring

Risk Based Monitoring

Bilingual (French/English)

Data Management

Site Management

Education

Bachelor's Degree

Tools

EDC Systems

IMPACT

IV/WRS

CATS

CONCUR

Job description

Senior Clinical Research Associate - Regional

Location: Home Based, 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 conducting remote and onsite monitoring of regional sites in a risk-based monitoring model.

Responsibilities:

1. Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout.
2. Ensure collection of high-quality data, timely adverse event reporting, subject protection and compliance to the protocol.
3. Adherence to ICH-GCP, Canadian regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines.
4. Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met.
5. Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones.
6. 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.
7. Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.
8. Prepares and completes monitoring visit reports and follow-up letters within the timeline established by the applicable SOPs and guidelines.
9. Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables.
10. 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.
11. Identify potential risks and proactively prevent or mitigate them.
12. 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:

1. Educational requirement: BA/BS
2. Years of experience: 4+ years of CRA (monitoring experience) - ideally looking for 5+ years of field CRA monitoring experience for drug trials.
3. Industry experience: 6+ years of clinical research industry experience.
4. Diabetes experience is a nice to have.
5. Remote Monitoring Experience.
6. Risk Based Monitoring experience.
7. Flexible and agile.
8. Comfortable with travel from Newfoundland to Saskatchewan.
9. Complex trial experience.
10. Bilingual French/English.

Working Conditions:

1. Works from a home office environment at least one day a week.
2. Works at hospitals, medical clinics three to four times a week.
3. May be required to drive, fly, or take train to location to perform duties of the job.
4. 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.

Ref: #568-Clinical