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    Project Coordinator

    Innovaderm Research
    2+ years
    Not Disclosed
    Canada
    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, Canada - North America

    Overview
    The Project Coordinator plays a vital role in supporting the Project Managers, Clinical Trial Managers (CTM), Site Selection Team, and Clinical Research Associates (CRAs) throughout the clinical trial lifecycle. The role focuses on ensuring smooth site activation activities and other site-level deliverables, ensuring that timeframes, targets, and quality meet both internal and external expectations.

    Responsibilities

    Site Activation and Coordination

    • Prepare clinical trial sites by reviewing and ensuring the approval of essential trial and regulatory documents.
    • Establish site activation timelines with selected sites and coordinate activities to meet those timelines.
    • Communicate with clinical sites during site start-up to ensure alignment of all activities with study timelines.
    • Collaborate with other functional departments to align site activation activities with overall project goals.
    • Escalate any risks to the site activation schedule to the Project Manager.
    • Ensure that all site-related tasks and priorities are aligned with the study timeline, maintaining constant communication with the study team and external site staff.
    • Collect, review, and file essential documents from sites, ensuring completeness and quality to facilitate smooth activation.
    • Ensure that the electronic Trial Master File (eTMF) contains relevant regulatory documents for site activation and ongoing study management.
    • Assist with local ethics submissions and provide support for internal and external teams accessing study-specific systems.

    Administrative and Project Support

    • Maintain project timeline dates, enrollment tracking tools, and study material inventory.
    • Coordinate shipments of study supplies to clinical sites, where applicable.
    • Assist in preparing for Investigator’s Meetings and distribute study correspondence to sites.
    • Serve as the in-house point of contact for CRAs when traveling.
    • Review and reconcile investigators' site and vendor payments.
    • Produce meeting minutes and track project status and reporting activities.
    • Maintain an ADI log and assist with internal project-specific training documentation.
    • Provide administrative support for project tracking and status report preparation.
    • Support Health Authority inspections, pre-inspection activities, and audit preparation.
    • May assist with corrective action or preventative action preparation for project-related issues.

    Ideal Profile

    Education

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

    Experience

    • Experience in clinical research within the biotechnology, pharmaceutical, or CRO industry is highly beneficial.

    Knowledge and Skills

    • Proficiency in English (both written and oral).
    • Strong competency in Microsoft Office (Word, Excel, PowerPoint).
    • Ability to prioritize assignments and meet deadlines under pressure.
    • High attention to detail and adaptability to changing priorities.
    • Excellent organizational, communication, problem-solving, and multitasking skills.
    • Quick learner with a versatile approach to tasks.

    Why Innovaderm?

    Work Environment and Benefits

    • Flexible work schedule and a permanent, full-time position.
    • Comprehensive benefits package: medical, dental, vision, RRSP, vacation, personal days, and more.
    • Offices located near public transportation (Sherbrooke or Saint-Laurent metro stations).
    • Option to work from home, subject to company policies.
    • Ongoing learning and development opportunities.

    About Innovaderm

    Innovaderm is a specialized contract research organization (CRO) focusing on dermatology. Since its inception in 2000, Innovaderm has built a strong reputation for providing high-quality research and services that exceed client expectations. With a team of over 175 employees, Innovaderm continues to grow and expand its reach across North America and Europe.

    Commitment to Equity
    Innovaderm is dedicated to providing equitable treatment and equal opportunities for all individuals. Accommodations will be made available throughout the recruitment process for applicants with disabilities, upon request.

    Note: Only candidates eligible to work in Canada will be considered.

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