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    Clinical Trial Coordinator - Boise, United States - Idaho State Job Bank

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    Description
    Clinical Trial Coordinator
    • E2E
    • Home Based (US) at ICON Strategic Solutions in Boise, Idaho, United States Job Description ICON plc is a world leading healthcare intelligence and clinical research organization.
    We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.


    What you will be doing:
    Clinical Trial Coordinator (CTC)

    Trial and site administration:
    + Track (e.g. essential documents) and report (e.g. Safety Reports) + Ensure collation and distribution of study tools and documents + Update clinical trial databases (CTMS) and trackers + Clinical supply & non-clinical supply management, in collaboration with other country roles + Manage Labeling requirements and coordinate/sign translation change request Document management: + Prepare documents and correspondence + Collate, distribute/ship, and archive clinical documents, e.g. eTMF + Assist with eTMF reconciliation + Execute eTMF Quality Control Plan + Update manuals/documents (e.g., patient diaries, instructions) + Document proper destruction of clinical supplies.


    • Prepare Investigator trial file binders Obtain translations of documents Regulatory & Site Start-Up responsibilities:

    Collaborate with other country roles to: + In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions + Obtain, track and update study insurance certificates + Support preparation of submission package for IRB/ERC and support regulatory + agencies submissions.


    • Publish study results for GCTO and RA where required per local legislation Budgeting, Agreement and Payments:

    Collaborate with finance/budgeting representatives for: + Develop, control, update and close-out country and site budgets (including Split site budget) + Develop, negotiate, approve and maintain contracts (e.g.

    CTRAs) + Track and report contract negotiations + Update and maintain contract templates (in cooperation with Legal Department) + Calculate and execute payments (to investigators, vendors, grants) + Ensure adherence to financial and compliance procedures + Monitor and track adherence and disclosures + Maintain tracking tools Meeting Planning:
    + Organize meetings (create & track study memos/letters/protocols) + Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

    What you need to have:

    Clinical Trial Coordinator (CTC) + Minimum 1-2 yrs in Clinical Research or relevant healthcare experience + Completed job training (office management, administration, finance, health care preferred) or B.A./B.S.

    (Life Science preferred) or equivalent healthcare experience + Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

    + Hands on knowledge of Good Documentation Practices + Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.

    Strong MS Excel skills required. + ICH-GCP Knowledge appropriate to role + Excellent negotiation skills for CTCs in finance area + Highly effective time management, organizational and interpersonal skills, conflict management + Effective communication with external customers (e.g. sites and investigators) + High sense of accountability / urgency.

    Ability to set priorities and handle multiple tasks simultaneously in a changing environment + Works effectively in a matrix multicultural environment.

    Ability to establish and maintain culturally sensitive working relationships. + Demonstrates commitment to Customer focus, both internally and externally. + Able to work independently taking full ownership of delegated tasks + Proactive attitude to solving problems / proposing solutions + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status + ICON is an To view full details and how to apply, please login or create a Job Seeker account


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