Worldwide Clinical Trials logo
Worldwide Clinical Trials

Established in 1986, Worldwide Clinical Trials is a privately held company and leading provider of clinical-trial research studies. As an employer, the company

Regulatory & Site Activation Specialist

Location

Australia

Posted

17 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Regulatory & Site Activation Specialist

Worldwide Clinical Trials

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality. • May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc. • Maintain country-specific patient information sheet and consent form customization text. • Maintain country-specific drug labeling information and Country Intelligence Pages. • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.

Job Requirements

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences
  • Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function
  • Previous experience within the pharmaceutical/CRO industry.
  • Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research.
  • Experience in regulatory submissions in Australia
  • Multilingualism preferred; working knowledge of English.

Benefits

  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events

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