- Conducting site initiation, routine monitoring, and close-out visits at investigator sites across Australia.
- Ensuring data integrity and accuracy through source data verification and review of clinical trial documents.
- Collaborating closely with study site staff and investigators to ensure adherence to study protocols and timelines.
- Identifying and resolving issues related to study conduct and site performance in a timely manner.
- Providing support for regulatory submissions and inspections as needed. Requirements:
- Minimum of 3 years of monitoring experience in clinical research, preferably in oncology studies.
- Bachelor's degree in a relevant scientific discipline or equivalent experience.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Excellent communication skills
- Ability to travel domestically for site visits as needed.
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Clinical Research Associate - Melbourne, Australia - i-Pharm Consulting
Description
Are you passionate about oncology?
If so, we have an exciting opportunity for you to join a leading CRO as a Clinical Research Associate (CRA) dedicated to oncology studies.
CRA II
Senior CRA
Principal CRA
You will be 100% sponsor dedicated (FSP) to a unique Biotech, where you will manage a range of early-phase clinical projects.
This business has seen some huge successes over the last few years and thus has had a lot of growth within the business. What this means for the employees who have joined so far is fast progression opportunities.
This role would suit someone who is able to conduct a range of monitoring visits and has strong sponsor/client management experience. In return, you will be offered a progressive career track with attainable growth to CPM.
Position Overview:
As a Clinical Research Associate (CRA), you will play a pivotal role in the execution of oncology studies sponsored by a leading biotech company. You will be responsible for monitoring and ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Key Responsibilities: