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    Project Coordinator (Spain)

    Innovaderm Research
    2+ years
    Not Disclosed
    Spain
    10 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, Spain - North America

    Overview
    The Project Coordinator supports Project Managers, Clinical Trial Managers (CTMs), Site Selection Teams, and Clinical Research Associates (CRAs) in coordinating and administrating site activation activities across all phases of the clinical trial lifecycle. You will be responsible for ensuring the timely completion of deliverables while meeting internal and external customer expectations. This position is ideal for those with project administration and clinical research experience who enjoy working 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 these timelines.
    • Communicate directly with clinical sites during the start-up phase, ensuring alignment with the project schedule.
    • Collaborate with other functional departments to ensure alignment of activities with site activation targets.
    • Escalate any risks or delays to the Project Manager regarding site activation schedules.
    • Ensure essential documentation is complete, of high quality, and meets first-pass review standards for site activation.
    • Maintain and manage the electronic Trial Master File (eTMF) to ensure it contains the relevant regulatory documents.
    • Collect, distribute, and file necessary documents between sites and internal teams.

    Administrative and Project Support

    • Produce meeting minutes from project meetings, maintaining clear records of discussions and actions.
    • Maintain the ADI log, track training activities, and support internal project-specific training documentation.
    • Assist with drafting study documents and clinical trial plans.
    • Act as a point of contact for site correspondences related to non-protocol issues.
    • Assist with local ethics submissions and provide support in accessing study-specific systems.
    • Help maintain study files, assemble Investigator’s Study Files, and manage shipments of study supplies to clinical sites.
    • Assist in preparing for Investigator’s Meetings and distributing study-related correspondence to sites.
    • Support CRAs during travel and review/reconcile investigator site and vendor payments.
    • Assist with project tracking activities and status report preparation.
    • Contribute to Health Authority inspections, pre-inspection activities, and audit preparations.
    • Provide support for corrective and preventative actions for project-related issues.

    Ideal Profile

    Education

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

    Experience

    • Prior experience in clinical research, ideally within the biotechnology, pharmaceutical, and/or CRO industry.

    Skills

    • Proficiency in English (both oral and written).
    • Strong knowledge of Microsoft Word, Excel, and PowerPoint.
    • Ability to prioritize assignments and work under pressure while maintaining attention to detail.
    • Quick learner with strong adaptability and versatility.
    • Excellent organizational, communication, problem-solving, and multitasking abilities.

    Why Innovaderm?

    Work Environment and Benefits

    • Flexible work schedule and a permanent full-time position.
    • Company benefits package, including health, dental, and vision coverage.
    • Ongoing learning and development opportunities to foster career growth.

    About Innovaderm

    Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. Established in 2000, Innovaderm has built a solid reputation for providing high-quality research and exceeding client expectations. Based in Montreal, Innovaderm is expanding its presence in North America and Europe.

    Commitment to Equity
    Innovaderm is committed 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: Innovaderm only accepts applicants who are legally eligible to work in Spain.

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