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Senior Clinical Research Operations Specialist

1 month ago

North Ryde, New South Wales, Australia Parexel Full time
Job Description

Parexel is seeking a highly motivated Senior Clinical Research Operations Specialist to join our team. This role will be responsible for the successful management of clinical trials from site identification through pre-initiation.

Key Responsibilities:
  • Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff to ensure seamless communication.
  • Conduct country specific feasibility and/or site pre-qualification and qualification activities, including preparation and negotiation of agreements.
  • Generate visit/contact reports, using judgment to identify site issues and problem-solving skills to direct resolution.
  • Develop strategies to configure, distribute, and collect high-quality country-specific and/or site-specific documents.
  • Customize, review, and negotiate Informed Consent Forms (ICF) and translations as needed.
  • Prepare and submit IRB/IEC and MoH/RA application(s), resolving conflicts and determining follow-up actions until receipt of final approval.
Requirements:
  • 1-2 years' experience in start-up experience is required.
  • Study Coordinator with start-up activities experience from site level may also be considered.
  • Excellent communication and problem-solving skills are essential.
Estimated Salary: $60,000 - $80,000 per year