Clinical Trial Coordinator Internship Ne

Clinical Trial Coordinator Internship
Ne
Liguria, Ne

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

Internship to cover eTMF filing, ISF building and lower level CTC tasks.

Job Description

ROLE

The Clinical Trial Coordinator assists the clinical research team ensuring to conduct study in accordance to GCP, SOP, protocol, and in respect of budget and timelines. The Clinical Trial Coordinator is responsible for start up activities and documents management.

KEY RESPONSIBILITIES

Responsible (under PM oversight) for start up activities, including Ethic and Regulatory submission (at national and international level) and sites contracts' negotiation. Responsible for ISF preparation and TMF set up and maintenance (under PM oversight). Maintains relationship with ECs and CA. Supports in sites/vendors invoicing management and is responsible for maintaining appropriate tracking if required. Collaborates with the preparation of weekly/monthly and ad hoc project reports, also updating CTMS and maintaining study-specific trackers as needed. Supports with CRAs activities follow-up. Supports with document translation, if required. Participates in internal, client/sponsor, scientific, and other meetings as required; participates in audits. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE

Graduation in scientific/health field. Previous experience in clinical research (in CROs, Pharma or academy/hospital experience). Good knowledge of ICH GCP and appropriate regulations. Good knowledge of Clinical Research and Regulatory/Ethical requirements. TECHNICAL COMPETENCES & SOFT SKILLS

MS Office Suite, Good. Professional. Trustworthy. 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. Strong communication and interpersonal skills with customer service orientation. Languages

Education

Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy.

Contract Type

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