Senior Clinical Trial Coordinator

4 giorni fa

Verona, Veneto, Italia Alira Health A tempo pieno

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 SENIOR CLINICAL TRIAL COORDINATOR ROLE

The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will collaborate with the Study Start-Up team. and ensures the start-up activities are performed both with quality and on time. They will oversee and mentor junior Clinical Trial Coordinators and junior team members as needed.

KEY RESPONSABILITIES

  • Responsible (under PM oversight and in conjunction with the Study Start-Up Team) for start-up activities, including Ethic and Regulatory submission (at national and international level) and sites contract negotiation.
  • Responsible for ISF preparation and TMF set up and maintenance (under PM oversight).
  • Training and support of junior CTCs for use of tools, e.g. CTMS.
  • Maintains relationship with ECs and CA for e.g device, observational, real-world evidence studies.
  • Supports in sites/vendors invoicing management and responsible to maintain an appropriate tracking if required.
  • Responsible for vendor management (under PM oversight).
  • 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 to audit.
  • 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

  • English, good
  • 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

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.

Languages

English

Education

Bachelor of Science (BS), Bachelor of Science (BS): Biology, Bachelor of Science (BS): Medicine

Contract Type

Regular

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