Job Overview
This is a Clinical Research Associate (CRA) position in our organization. The role of the CRA is crucial for ensuring compliance with protocols and regulatory requirements.
You will work closely with investigative sites, client companies, and the project team to facilitate effective communication and data collection. This position requires strong organizational and time management skills, as well as excellent interpersonal and communication skills.
The ideal candidate will have a bachelor's degree in a life sciences related field or equivalent, and at least 4 years of independent monitoring experience in Australia. Therapeutic experience in Oncology and Phase I experience are also essential.
Responsibilities
* Perform and coordinate all aspects of clinical monitoring and site management
* Conduct remote or on-site visits to assess protocol and regulatory compliance
* Manage required documentation and procedures
* Act as a site process specialist to ensure trial conduct according to approved protocol, ICH-GCP guidelines, and SOPs
* Provide trial status tracking and progress update reports
* Participate in investigator meetings and identify potential investigators
* Initiate clinical trial sites and ensure compliance with protocol and regulatory obligations
* Ensure trial close out and retrieval of trial materials