Project Coordinator


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:

  • Prepare 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.
  • Communicate 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.
  • Acts as a main point of contact for all site correspondences for non-protocol related issues.
  • Assists sites with local ethics submissions.
  • Assist internal and external teams with access to study-specific systems
  • Assist with initiating and maintaining study files.
  • Prepares shipments of study supplies to clinical sites, when applicable.
  • Assists with preparation of Investigators’ Meeting.
  • Distributes study correspondence to sites.
  • Serves as in-house contact to support CRAs when traveling.
  • Reviews and reconciles investigators site and vendor payments.

 

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.

 

Knowledge and skills 

  • 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.

 

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. 

 

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

  • Flexible work schedule
  • Permanent full-time position
  • Ongoing learning and development

 

Work location 

The successful candidate for this position is given to work remotely anywhere in Poland.

Employees located outside of North America are expected to have some flexibility in their working hours to accommodate team or client meetings as needed. All efforts will be made by Innovaderm to accommodate various time zones of team members. 

 

Covid-19 vaccination policy: The health and safety of all is important to us. In accordance with the applicable vaccination policy, Innovaderm demands that all employees present at its offices as well as all client and vendor sites (including clinical sites) be adequately vaccinated, under reserve of exemptions related to adaptation requirements prescribed by law.

 

About Innovaderm 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, 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 Poland.

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