- 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.
- Prepare Investigator trial file binders Obtain translations of documents Regulatory & Site Start-Up responsibilities:
- Publish study results for GCTO and RA where required per local legislation Budgeting, Agreement and Payments:
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Clinical Trial Coordinator - Boise, United States - Idaho State Job Bank
Description
Clinical Trial CoordinatorWhat 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.
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.
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