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    AL

    Alira Health

    Healthcare

    Clinical Trial Coordinator I

    Munich, GermanyHybridFull-timePosted 6d ago
    All Alira Health jobs

    Job description

    đź”—Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

    Job Description Summary

    Job Description

    THE CLINICAL TRIAL COORDINATOR I ROLE

    The Clinical Trial Coordinator (CTC) I assists the clinical research team, supporting Project Managers (PMs), Study Start-up team, Clinical Research Associates (CRAs), and clinical sites to ensure studies are conducted in accordance with ICH GCP, applicable laws, SOPs, and the protocol in respect of study budget and timelines.

    ESSENTIAL JOB FUNCTIONS

    • Responsible (in collaboration with PM, CRAs, and Study Start-up team, as applicable) for site identification and feasibility, including initial site outreach, follow-up, and circulation and collection of feasibility questionnaires and Non-disclosure Agreements (NDAs)
    • Supports PM with the  management of and participation in internal, client/sponsor, scientific, and other meetings as required, including but not limited to supporting with scheduling meetings and preparing agendas and meeting minutes
    • Responsible (under PM oversight and in collaboration with Study Start-up team, as applicable) for site start-up activities, including Ethics Committees and Institutional Review Boards and Regulatory submissions (at site, national, and international level, as applicable) and site contract and budget negotiation
    • Maintains relationships with Ethics Committees (ECs) and Competent Authorities (CAs), as applicable
    • Responsible for document management including Trial Master File (TMF) setup maintenance and TMF QC (under PM oversight)
    • Supports PM with Investigator Site File (ISF) preparation and distribution to sites
    • Supports the PM with the management of study site supplies
    • Supports collection and review of site Essential Documents, in collaboration with CRAs
    • May support regular communication with sites to address questions, ensure protocol/GCP compliance, determine study progress and monitor subject accrual
    • Supports PM with study management activities throughout life cycle of study; collaborates in the preparation of weekly/monthly and/or ad hoc project reports, updating CTMS, and maintaining study-specific trackers as needed
    • Supports PM with maintenance of study team training materials
    • Supports PM with site/vendor invoicing management, as applicable
    • Supports CRAs with follow-up activities
    • Supports PM with document translation, as applicable
    • Participates in audits, as applicable
    • Performs additional duties as assigned

    PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

    • Graduation in scientific/health field or equivalent experience
    • Strong command of English, both written and verbal
    • Proficient with MS Office Suite
    • Quality focused; ability to be careful, thorough, and detail-oriented
    • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
    • Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges
    • Strong communication and interpersonal skills with customer service orientation
    • Professional and trustworthy
    • Permanent authorization to work in applicable country(-ies)
    • Previous experience preferred or ability to quickly learn ICH GCP principles and appropriate Regulatory/Ethical requirements.

    Salary Range

    Euro 30.000 - 50.000

    Languages

    English

    Education

    Bachelor of Science (BS)

    Contract Type

    Regular

    Salary Range

    The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

    EUR 30,000 - 50,000 gross annually

    Job details are sourced from the employer's original posting.

    Open job posting
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    About the company

    Alira Health

    Alira Health is a global team dedicated to innovation and initiative in the healthcare industry, focusing on collaboration and shared values.

    View all Alira Health jobs
    Industry
    Healthcare
    Open roles
    35

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