Clinical Research Coordinator
1 dzień temu
We are seeking a highly organized and detail-oriented Project Coordinator to join our team at Innovaderm Research. As a Project Coordinator, you will play a critical role in supporting the successful execution of clinical trials.
Key Responsibilities- Prepare Investigator Sites for clinical trials by reviewing and approving essential documents.
- Establish site activation timelines and coordinate activities to meet planned timelines.
- Communicate with clinical sites during site start-up and ensure alignment of tasks and priorities.
- Collaborate with other functional departments to ensure site activation targets are met.
- Escalate risks to site activation schedule to the Project Manager.
- Collect, review, and file essential documents for site activation.
- Ensure electronic Trial Master File (eTMF) contains relevant regulatory documents.
- Collect and distribute documents from/to sites.
- Produce meeting minutes from project meetings.
- Maintain ADI log and assign documents for internal project-specific training.
- Assist with drafting study documents and study plans.
- Act as main point of contact for site correspondences.
- Assist with local ethics submissions and site initiation.
- Support internal and external teams with access to study-specific systems.
- Assist with study file maintenance and Investigator's Study File preparation.
- Maintain project timeline dates, enrolment tracking tools, and study material inventory.
- Prepare shipments of study supplies to clinical sites.
- Assist with Investigators' Meeting preparation and distribute study correspondence.
- Support CRAs during travel and review/reconcile investigator site and vendor payments.
- Assist with project tracking activities and status reports preparation.
- Participate in administrative tasks as required.
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment and attractive advancement opportunities. As a Project Coordinator, you will be eligible for a flexible work schedule, permanent full-time position, vacation, PPK, health allowance, home-based position with teleworking allowance, and ongoing learning and development.
Requirements- 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 the biotechnology, pharmaceutical, and/or CRO industry is 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 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.
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