Sought after Clinical Research Professional

2 weeks ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $90,000 - $110,000
Senior Clinical Research Associate Job Opportunity

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our organization. As a Senior CRA, you will play a critical role in ensuring the successful management of clinical trials from start to finish.

The ideal candidate will have a strong background in life sciences and extensive experience in monitoring clinical trials in a contract research organization or pharmaceutical industry setting. You will be responsible for all aspects of study site management, including feasibility, site selection, initiation, interim monitoring, close-out, and maintenance of electronic Trial Master Files (eTMFs).

You will work closely with project managers to ensure timely completion of projects, manage site budgets, and negotiate site contracts. Additionally, you will oversee all aspects of study site management to ensure high-quality data, maintain eTMF filing, and track studies in Clinical Trial Management Systems (CTMS).

Key Responsibilities:

  • Perform site qualification visits to discuss protocol, study documentation, and requirements with investigators and trial staff.
  • Support feasibility, site selection, and start-up activities, including HREC submissions.
  • Negotiate site budgets and assist with contract execution.
  • Conduct site initiation visits to train investigators and staff on protocol and data collection methods.
  • Perform interim monitoring visits to ensure adherence to protocol and monitor participant source data.
  • Close out sites and maintain eTMF filing.
  • Maintain study tracking in CTMS and manage timely site payments.

Requirements:

  • Undergraduate degree in Life Sciences (Biology, Chemistry, Pharmaceuticals)
  • At least 3-4 years' experience in monitoring clinical trials as a SCRA/CRA
  • Experience in early phase oncology trials is preferred
  • Familiarity with EDC & CTMS systems
  • Contract negotiation and HREC submission preparation experience desirable
  • Strong understanding of ICH-GCP requirements
  • Ability to travel as required

About Us:

We are a progressive and passionate team of healthcare professionals united by a common purpose: to design care experiences that deliver the best possible life outcomes. We believe in creating a workplace where everyone can thrive.

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