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Ključne odgovornosti
  • conducting on-site and remote monitoring visits across study phases
  • verifying investigational site compliance and capability
  • site initiation
  • staff training
  • regulatory support
  • mentorship of junior monitoring staff

Zahtjevi

bullseye

Potrebne kvalifikacije

Iskustvo
extensive on-site monitoring experience in Phase II/III trials
Obrazovanje
College or university degree in life sciences or equivalent education and experience
Soft vještine
Strong planning, multitasking, and teamwork abilities
Excellent communication, collaboration, and problem-solving skills
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Poželjne kvalifikacije

Dodatne vještine
Experience with complex trials in oncology or rare disease
Originalan opis

Clinical Research Associate II at Ergomed responsible for conducting on-site and remote monitoring visits across study phases to verify investigational site compliance and capability. The role includes site initiation, staff training, regulatory support, and mentorship of junior monitoring staff.

Responsibilities

  • Conduct pre-study, initiation, interim, and close-out monitoring visits at investigational sites
  • Verify investigator qualifications, resources, facilities, equipment, and staffing adequacy
  • Train investigational site staff as needed for study conduct
  • Support preparation of regulatory and ethics committee submissions when applicable
  • Mentor junior staff and perform co-monitoring visits to assess performance

Requirements

  • College or university degree in life sciences or equivalent education and experience
  • Extensive on-site monitoring experience in Phase II/III trials
  • Experience with complex trials in oncology or rare disease preferred
  • Fluent English language proficiency
  • Strong planning, multitasking, and teamwork abilities
  • Valid driving license and willingness to travel
  • Excellent communication, collaboration, and problem-solving skills
Oglas je objavljen prije 6 dana