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Senior Project Coordinator (Clinical Research)


The Senior Project Coordinator works with Project Managers, Clinical Trial Managers, and Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities 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. 

This role is perfect for you if:

  • You have an experience 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 Senior Project Coordinator:

 

  • Leads the site activation planning with investigator sites for assigned projects
  • Communicates with research sites regarding the distribution of site essential documentation and determine individualized site startup timelines
  • Organizes the workflow to ensure investigator sites are prepared to optimize overall site activation timelines for the study from first site initiated to last site initiated.  
  • Throughout the study ensure investigator sites regulatory documentation is collected, filed, and remains current. May review site essential regulatory documents to ensure that the quality and accuracy of the submitted documentation meets clinical trial standards.
  • Ensures Clinical Trial Package (CTP) documentation is complete and of good quality to successfully first pass review for site activation.
  • Escalates to the Project Manager risks to site activation schedule.
  • Collects, reviews and files sites essential documents required for Clinical Trial Package.
  • Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
  • Collects and distributes documents from / to sites including obtaining insurance certificates.
  • Schedules project meetings and produces meeting minutes.
  • Maintains currency of ADI log.
  • Distributes documents for internal project-specific training and coordinates training documentation.
  • Assist with initiating and maintaining study files.
  • Assist with assembling and shipping the Investigator’s Study File.
  • Maintains project timeline dates, enrolment tracking tools, and study material inventory.
  • Assists Project Managers and Recruitment Specialist team with study material inventory and the maintenance of enrolment tracking tools, respectively.
  • Prepares shipments of study supplies to clinical sites, when applicable.
  • Assists with preparation of Investigators’ Meeting.
  • Distributes study correspondence to sites.
  • Assists with preparing investigators 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 audit preparation & Corrective Action / Preventative Action preparation for project related issues.

 

IDEAL PROFILE

 

  • Bachelor’s degree in a field relevant to clinical research or equivalent experience;
  • Specialized graduate diploma in drug development is an asset;
  • Experience in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry, an asset;
  • Excellent oral and written skills in English, French is an asset;
  • Excellent knowledge and competency in Word, Excel and Power Point;
  • Ability to prioritize different assignments and work under pressure;
  • Attention to detail and meet timelines;
  • 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. 

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

  • Flexible work schedule
  • Permanent full-time position
  • Signing bonus
  • 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 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 Canada. 

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