Senior Clinical Research Associate – FSP

This is a fully remote position, open to applicants in Australia.

📋 Description

• Supervision of Monitoring Duties and Study Implementation

• Ensure that clinical trials are conducted properly according to the Study Monitoring Plan (SMP), relevant regulations, Good Clinical Practice (GCP), and client standards to meet project objectives, timelines, and quality benchmarks

• Oversee operational components for the execution of clinical trial activities at designated investigator sites, from site activation to database lock, ensuring adherence to timelines and quality deliverables

• Act as the main point of contact for assigned investigator sites throughout the study

• Collaborate with and/or escalate issues to the SCP to maintain site delivery quality

• Liaise with the study team as necessary, facilitating communication among study team members, vendors, and designated investigator sites

• Work alongside the SCP to assist in the development, coaching, and training of site personnel to ensure continuous protocol compliance

• Provide protocol training to investigator site staff and address any protocol-related inquiries, including discussions on known or anticipated operational and clinical trial risks

• Attend investigator meetings as required (either virtual or face-to-face)

• Offer enrollment assistance and ensure progress by addressing site activation and recruitment challenges from investigators

• Conduct onsite, remote, or electronic monitoring as required for study site initiation, routine monitoring, and study site closure activities

⛳️ Requirements

• At least 3 years of relevant experience in clinical research site monitoring (preferably 2 years in Oncology)

• Desired therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases

• Experience in global clinical trials

• Must be proficient in English and the native language(s) of the country where they will be working

• A valid driver’s license and passport are required

🏝️ Benefits

• N/A