Clinical Trials Operations Specialist

1 week ago

Armidale, New South Wales, Australia beBeeOperations Full time $100,000 - $150,000
Job Description

Clinical trials are a crucial aspect of medical research, and the success of these trials relies heavily on the efficient conduct of clinical trial monitoring.

We are seeking a skilled Clinical Trials Operations Specialist to manage assigned operational aspects for the implementation of clinical trial activities at assigned investigator sites. This includes ensuring relevant timelines and quality deliverables are met.

This role requires strong communication skills as the primary point of contact for assigned investigator sites, working in partnership with the Study Coordinating Partner (SCP) to ensure quality of site delivery.

Key Responsibilities
  • Collaborate with the study team to facilitate information flow between members of the study team, vendors, and assigned investigator sites.
  • Partner with SCP to perform investigator site development, coaching, and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients.
  • Attend investigator meetings when required, either virtually or in-person.
  • Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.
  • Work closely with SCP and the study team to define and support recruitment initiatives at site level.

Monitor site-level adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit to bring SAE reports to resolution.

Requirements and Qualifications

To be successful in this role, you should have:

  • Experience in clinical trial operations, preferably in a similar position.
  • Excellent communication and organizational skills.
  • Able to work independently and as part of a team.
  • Familiarity with Good Clinical Practices (GCP).

In return, we offer a competitive compensation package that reflects your hard work and dedication.

You will also have the opportunity to work on high-profile projects and collaborate with experienced professionals in the field.

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