Research Site Manager

6 days ago

Alton Downs, Australia beBeeClinical Full time $120,000 - $140,000
Senior Clinical Research Associate

We are seeking a highly skilled professional to play a key role in monitoring clinical trials and ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.

Key Responsibilities:

  • Act as a member of the project team with the goal to contribute towards efficient management of trials.
  • Perform site qualification visits: discuss protocol, other available study documentation, and study requirements with investigator and other trial staff, ensures that trial staff and site facilities and the site's recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP, and GC CRO's SOPs.
  • Support feasibility, site selection, and start-up activities, including leading the preparation of human research ethics committee submissions with sites.
  • Negotiate site budgets and assists with the execution of site contracts with support from the project manager.
  • Perform site initiation visits: trains investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP, and GC CRO's SOPs.
  • Perform interim monitoring visits: ensures adherence to protocol, monitor participant source data via source document verification per the monitoring plan, and perform investigational product accountability, meet with site staff, and ensure study procedures are conducted in accordance with the protocol and informed consent GCP.
  • Perform site close-out visits.
  • Oversee all aspects of study site management to ensure high-quality data.
  • Maintain electronic trial master filing.
  • Maintain study tracking in clinical trial management system in a timely manner.
  • Manage timely site payments.
  • May be delegated with project manager-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, pharmaceutical, and/or biotechnology industry as a senior clinical research associate/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.

About GenesisCare:

By joining genesis care, you will be joining a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes.

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