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Clinical Trials Manager

2 weeks ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $120,000 - $150,000

Senior Clinical Research Associate Role

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We are seeking an experienced professional to join our team as a Senior Clinical Research Associate. This is an exciting opportunity for someone who is passionate about innovation and working together to drive better life outcomes for patients worldwide.

About the Role:

The successful candidate will be responsible for monitoring clinical trials, ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines. As a member of the project team, the goal will be to contribute towards efficient management of trials.

Main Responsibilities:

  • Act as a member of the project team to contribute towards efficient trial management.
  • Perform site qualification visits to ensure trial staff, facilities, and recruitment potential meet protocol requirements, local regulations, ICH-GCP, and GC CRO's SOPs.
  • Support feasibility, site selection, and start-up activities, including preparing HREC submissions with sites.
  • Negotiate site budgets and assist with executing site contracts with support from the PM.
  • Perform site initiation visits to train investigators and other trial staff in the protocol and data collection methods, ensuring accurate, complete, and conforming patient data.
  • Perform interim monitoring visits to ensure adherence to protocol, monitor participant source data via source document verification per the monitoring plan, perform Investigational Product accountability, and meet with site staff to ensure study procedures are conducted in accordance with the protocol and ICF GCP.
  • Perform site close-out visits.
  • Oversee all aspects of study site management to ensure high-quality data.
  • Maintain eTMF filing.
  • Maintain study tracking in Clinical Trial Management System (CTMS) in a timely manner.
  • Manage timely site payments.
  • May be delegated PM-related tasks where appropriate.

Requirements:

  • An Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
  • At least 3-4 years' experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industry as a SCRA/CRA.
  • Experience in managing early phase oncology trials is highly preferred.
  • Experience in EDC & CTMS.
  • Experience in all aspects of site management from feasibility, start-up site selection to site close-out.
  • Experience in contract negotiation desirable.
  • Experience in HREC submission preparation.
  • Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.
  • Willingness to travel to fulfill the requirements of the role.

Benefits:

  • Opportunities to develop professionally and learn every day.
  • Exposure to early site engagement from feasibility and start-up periods to build relationships with sites.
  • Direct work with sponsors on assigned projects.
  • Internal and external training and development opportunities.
  • Free confidential support for employees and their families, including financial, nutritional, and wellbeing coaching, legal advice, and counseling.
  • A range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount.