Project Coordinator, Early Phase

Project Coordinator, Early Phase

Canada

CRO - Project Management

Full-time

The 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 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.

This role is perfect for you if :

• You have an interest in project administration and clinical research;
• You want to work in a collaborative environment;
• You want to have an impact in a fast-growing company.

RESPONSIBILITIES

More specifically, the Project Coordinator :

• Assists in the process of site selection, including tracking of feasibility questionnaires and clinical study agreements with sites.
• Prepares Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines.
• Communicates with clinical sites during site start-up.
• Collaborates with other functional departments to ensure alignment of activities to meet site activation targets.
• Escalates to the Project Manager risks to site activation schedule.
• Communicates directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.
• Collects, reviews and files sites essential documents.
• Ensures essential documentation is complete and of good quality to successfully first pass review for site activation.
• Ensures that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
• Collects and distributes documents from / to sites.
• Produces meeting minutes from project meetings.
• Maintains ADI log.
• Assigns documents for internal project-specific training and coordinates training reconciliation and documentation.
• Assists with drafting of study documents and study plans for clinical trials.
• Acts as a main point of contact for all site correspondences for non-protocol related issues and distribution of protocol related issue communications.
• Assists sites with local ethics submissions.
• Assists internal and external teams with access to study-specific systems
• Assists with initiating and maintaining study files.
• Assists with assembling and shipping the Investigator’s Study File.
• Maintains project timeline dates, enrolment tracking tools, and study material inventory.
• Prepares shipments of study supplies to clinical sites, when applicable.
• Assists with preparation of Investigators’ Meeting and / or study specific training.
• Distributes study correspondence to sites.
• Serves as in-house contact to support CRAs when traveling.
• Reviews and reconciles investigators site and vendor payments.
• Assists with project tracking activities and status reports preparation.
• Participates 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 & Corrective Action / Preventative Action preparation for project related issues.
• May perform project management duties on designated trials.

IDEAL PROFILE

Education

• Bachelor’s degree in a field relevant to clinical research or equivalent experience;
• Specialized graduate diploma in drug development is an asset;

Experience

Experience in clinical research and in the biotechnology, pharmaceutical, and / or CRO industry, an asset;

Knowledge and skills

• Excellent oral and written skills in English, French 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;
• Ability to work in a team environment and establish good relationships with colleagues and sponsors;
• Good problem-solving, critical- and creative-thinking abilities;
• Strong scientific acumen;
• Strong organizational, communication, and multi-tasking skills.

OUR COMPANY

The work environment

At Innovaderm, 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.

As a Project Coordinator, you will be eligible for the following perks :

• Flexible work schedule
• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• 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 Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in , our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients.

Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

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

Innovaderm only accepts applicants who can legally work in Canada.