Senior Project Coordinator / Coordonnateur Senior de projet

Indero (formerly Innovaderm); Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

A global clinical research organization is seeking a Senior Project Coordinator to manage site activation for clinical trials. The ideal candidate has experience in project coordination and a strong background in clinical research. The role involves ensuring timelines and quality standards are met while collaborating with project teams. The position offers flexible scheduling and comprehensive benefits in a supportive work environment.

Benefits

Flexible work schedule

Complete benefits

Offices near public transportation

Possibility of working from home

Ongoing learning and development

Qualifications

• Minimum of 2 years of experience as a Project Coordinator in clinical research.
• Proven experience managing clinical trials in a global environment.
• Bilingual French and English or fluency in another language is an asset.

Responsibilities

• Prepare Investigator Sites and manage clinical trial documents.
• Establish activation timelines and communicate with clinical sites.
• Assist with mentorship and onboarding activities for junior coordinators.

Skills

Site Start-Up experience

Attention to detail

Organizational skills

Communication skills

Problem-solving skills

Education

Bachelor’s degree in clinical research or equivalent

Specialized graduate diploma in drug development

Tools

Word

Excel

Power Point

Job description

Overview

The Senior Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle.

As a Senior Project Coordinator, you will take the lead to ensure timeframes, targets and the quality of the deliverables are in line with internal and external customer expectations. As a senior member of the team, you work autonomously to ensure optimized site activation and maintenance and you may be asked to mentor junior project coordinators.

Responsibilities

• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Establish site activation timelines with selected sites and coordinate activities to meet planned activation timelines.
• Communicate with clinical sites during site start-up.
• Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
• Escalate risks to the site activation schedule to the Project Manager.
• Communicate directly with study teams and external site staff to ensure tasks and priorities align with defined study timelines.
• Collect, review and file sites essential documents.
• Ensure essential documentation is complete and of good quality to successfully first pass review for site activation.
• Ensure the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
• Collect and distribute documents from/to sites.
• Produce meeting minutes from project meetings.
• Maintain ADI log.
• Assign documents for internal project-specific training and coordinate training reconciliation and documentation.
• May assist with drafting of study documents and study plans for clinical trials.
• Act as a main point of contact for site correspondences for non-protocol related issues.
• Assist sites with local ethics submissions.
• Assist internal and external teams with access to study-specific systems.
• Assist with initiating and maintaining study files.
• Assist with assembling and shipping the Investigator’s Study File.
• Maintain project timeline dates, enrolment tracking tools, and study material inventory.
• Prepare shipments of study supplies to clinical sites, when applicable.
• Assist with preparation of Investigators’ Meeting.
• Distribute study correspondence to sites.
• Serve as in-house contact to support CRAs when traveling.
• Review and reconcile investigators site and vendor payments.
• Assist with project tracking activities and status reports preparation.
• Participate in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation and Corrective Action / Preventive Action (CAPA) preparation for project related issues.
• May perform project management duties on designated trials.
• May mentor junior Project Coordinators and assist with onboarding activities.
• May assist with process improvement and creation of training material within the Site Activation and Project Coordination department.

Requirements

• Bachelor’s degree in a field relevant to clinical research or equivalent experience.
• Specialized graduate diploma in drug development is an asset.
• Minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.
• Proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.
• Good knowledge of essential documentation requirements for clinical trials.
• Proficiency in English (written and oral) is required.
• Bilingual French and English or fluency in another European or Asian language is an asset.
• Excellent knowledge and competency in Word, Excel, and Power Point.
• Ability to prioritize multiple assignments to meet deadlines.
• Attention to detail.
• Quick learner, good adaptability and versatile.
• Strong organizational, communication, problem-solving and multi-tasking skills.

Company

Our company:

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Complete benefits
• Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
• Possibility of working from home in accordance with company policies and public health directives
• Ongoing learning and development

About Indero

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years of experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.