Clinical Research Associate
CRA20082024_1724136929
Posted: 20/08/2024
- Melbourne, Victoria
- Permanent
A chance to join an award winning, Australian CRO. With 15 years industry experience, this company have a wealth of presence in the industry and continue to grow after recent project successes. Partnering with a range of pharmaceutical and biotechnology companies.
Being a small-mid sized company, you will be working directly alongside senior management and will have a host of responsibilities which is great to upskill. You will be given full autonomy, working on a range of projects, including niche oncology.
You will be joining a small team, working with senior management and so offers strong progression opportunities and chances to up-skill in other areas of the business. They have built a strong team with close working relationships which is a priority for the business.
They offer a supportive work environment with flexible on site requirements and manageable workloads.
Ideal for a seasoned Clinical Research Associate with a minimum of 1 year CRO/Pharma monitoring experience.
Key Responsibilities:
- Initiate, monitor, and conclude site visits globally, ensuring adherence to protocols and regulatory standards.
- Identify suitable global clinical trial sites through site selection and qualification activities.
- Collaborate with cross-functional teams, including investigators and project managers, to ensure seamless trial execution.
- Verify clinical data accuracy and compliance with study protocols and regulatory requirements.
- Maintain essential study documentation, including regulatory submissions and monitoring reports.
- Address and escalate issues related to patient safety, data integrity, or study conduct.
- Contribute to protocol development, case report forms (CRFs), and other study-related documents.
- Train and mentor junior CRAs, offering support as required.
Qualifications:
- Bachelor's degree in a scientific or healthcare discipline; advanced degree preferred.
- Minimum 1 year experience as a Clinical Research Associate, ideally in global clinical trials.
- Proficiency in ICH-GCP guidelines, local and international regulatory requirements, and industry standards.
Position Details:
Title: Senior CRA
Location: Melbourne, South Australia, Western Australia
To apply for this opportunity, please submit your updated resume or contact Keeley Munday at 02 8310 5854.
Related Keywords: Clinical Research Associate, CRA, Global Clinical Research Organisation, global clinical trials, therapeutic areas, ICH-GCP guidelines, site selection, data integrity, patient safety, regulatory compliance, cross-functional teams, site visits, biotech-sponsored projects, mentoring, junior CRAs, EDC systems, global travel, professional growth, innovation, impactful research, healthcare
Keeley Munday
Principal Candidate Consultant
