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    Project Coordinator (Poland)

    Innovaderm Research
    2+ years
    Not Disclosed
    Poland
    12 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Project Coordinator - Innovaderm (Poland)

    Overview
    As a Project Coordinator, you will work closely with Project Managers, Clinical Trial Managers, Site Selection Teams, and Clinical Research Associates (CRAs) to provide administrative and coordinating support for site activation and other site-level deliverables throughout all phases of the clinical trial lifecycle. Your role will ensure that timeframes, targets, and the quality of deliverables are in line with internal and external customer expectations. This position is perfect for individuals with project administration and clinical research experience who thrive in a collaborative, fast-paced environment.

    Responsibilities

    Site Activation and Coordination

    • Review and approve essential clinical trial and regulatory documents to prepare Investigator Sites for clinical trials.
    • Establish site activation timelines with selected sites and coordinate activities to meet planned activation deadlines.
    • Communicate with clinical sites during the start-up phase, ensuring alignment with study schedules and goals.
    • Collaborate with other departments to align activities and meet site activation targets.
    • Escalate potential risks to the Project Manager related to site activation schedules.
    • Ensure that essential documentation is complete and of high quality to meet the first-pass review for site activation.
    • Ensure that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for both site activation and ongoing study management.
    • Manage the collection, distribution, and filing of documents from/to sites.
    • Produce meeting minutes and maintain accurate logs of project activities.
    • Coordinate internal training and ensure training documentation is properly filed.
    • Act as the primary contact for non-protocol related site correspondence.
    • Assist with local ethics submissions and facilitate access to study-specific systems.

    Administrative and Project Support

    • Assist with initiating and maintaining study files and assembling Investigator’s Study Files.
    • Track project timelines, enrollment tools, and study material inventories.
    • Prepare and distribute shipments of study supplies to clinical sites when applicable.
    • Assist with the preparation of Investigators’ Meetings and distribution of study correspondence to sites.
    • Provide in-house support for CRAs during travel and assist in reconciling investigator site and vendor payments.
    • Support project tracking activities and assist with status report preparations.
    • Participate in administrative tasks as required to meet project and team goals.
    • Contribute to Health Authority inspection activities, audit preparation, and corrective action planning.
    • Potentially perform project management duties for designated trials.

    Ideal Profile

    Education

    • Bachelor’s degree in a field related to clinical research or equivalent experience.
    • A specialized graduate diploma in drug development is considered an asset.

    Experience

    • Experience in clinical research, particularly in the biotechnology, pharmaceutical, and/or CRO industry, is advantageous.

    Skills

    • Proficiency in English (oral and written); French is an asset.
    • Strong competency in Microsoft Word, Excel, and PowerPoint.
    • Ability to prioritize tasks, work under pressure, and meet deadlines with attention to detail.
    • Quick learner with adaptability and versatility.
    • Strong organizational, communication, problem-solving, and multitasking skills.

    Why Innovaderm?

    Work Environment
    At Innovaderm, you will work alongside brilliant and driven colleagues. Our values of collaboration, innovation, reliability, and responsiveness shape our work culture. We offer a stimulating work environment and attractive advancement opportunities.

    Benefits

    • Flexible work schedule
    • Permanent full-time position
    • Vacation, health allowance, and PPK (Polish pension scheme)
    • Home-based position with teleworking allowance
    • Ongoing learning and development opportunities

    About Innovaderm

    Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. Established in 2000, Innovaderm has earned a solid reputation for delivering high-quality research and services, exceeding the expectations of its clients. With offices in Montreal, Innovaderm is growing and expanding in North America and Europe.

    Commitment to Equity
    Innovaderm is dedicated to providing equitable treatment and equal opportunities for all individuals. We offer accommodations throughout the recruitment and selection process for applicants with disabilities, upon request.

    Note
    Innovaderm only accepts applicants who are legally eligible to work in Poland.

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