Clinical Trials Monitoring Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $122,830 - $229,523
Senior Clinical Research Associate Position

Are you a highly motivated and experienced clinical research professional seeking a challenging opportunity to utilize your skills in monitoring clinical trials? We are currently recruiting for a Senior Clinical Research Associate to join our team.

This role involves taking responsibility for monitoring clinical trials, ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines. Key responsibilities include acting as a member of the project team, performing site qualification visits, supporting feasibility and site selection activities, negotiating site budgets, and conducting site initiation, interim monitoring, and close-out visits.

The successful candidate will have an undergraduate degree in Life Sciences, at least 3-4 years' experience in monitoring clinical trials, preferably in the CRO, Pharmaceutical, or Biotechnology industry. Experience in managing early phase oncology trials is highly preferred, as well as expertise in EDC and CTMS systems. Additionally, the ability to negotiate contracts and prepare HREC submissions is desirable.

As a Senior Clinical Research Associate, you will be responsible for overseeing all aspects of study site management, ensuring high-quality data, and maintaining eTMF filing and study tracking in Clinical Trial Management Systems (CTMS). You will also manage timely site payments and ensure that project documentation is obtained and maintained in a timely and compliant manner according to project requirements.

GenesisCare is committed to providing equal opportunities for all applicants.

  • Responsibilities:
  • Monitor clinical trials, ensuring compliance with SOPs, regulations, and ICH guidelines.
  • Act as a member of the project team, contributing to efficient trial management.
  • Perform site qualification visits, discussing protocol and other available study documentation with Investigators and trial staff.
  • Support feasibility, site selection, and start-up activities, including leading the preparation of HREC submissions.
  • Negotiate site budgets and execute site contracts with support from the Project Manager.
  • Conduct site initiation, interim monitoring, and close-out visits, training Investigators and trial staff in protocol and data collection methods.
  • Oversee all aspects of study site management, ensuring high-quality data and maintaining eTMF filing and study tracking in CTMS.
  • Manage timely site payments and ensure project documentation is obtained and maintained in a timely and compliant manner.
  • Requirements:
  • Undergraduate degree in Life Sciences.
  • At least 3-4 years' experience in monitoring clinical trials, preferably in the CRO, Pharmaceutical, or Biotechnology industry.
  • Experience in managing early phase oncology trials is highly preferred.
  • Expertise in EDC and CTMS systems.
  • Ability to negotiate contracts and prepare HREC submissions.
  • Excellent communication and problem-solving skills.

Why GenesisCare? As a leading healthcare provider, we offer a supportive and dynamic work environment that fosters professional growth and development. Our commitment to excellence and patient care makes us an employer of choice for talented professionals like you.

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