At a Glance
- Tasks: Conduct site visits and ensure compliance with research protocols.
- Company: Leading clinical research organisation focused on innovation.
- Benefits: Attractive salary, health benefits, flexible hours, and career development.
- Other info: Fast-paced environment with opportunities for growth and learning.
- Why this job: Join a dynamic team and contribute to groundbreaking medical research.
- Qualifications: Bachelor's in health or science; experience in clinical research preferred.
The predicted salary is between 67500 - 82500 $ per year.
Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
Communication with the medical site staff including coordinators, clinical research physicians and their site staff.
Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
Verification that the investigator is enrolling only eligible subjects.
Regulatory document review.
Investigational product/drug accountability and inventory.
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.
Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Requirements:
- Bachelor's degree in a health or science related field.
- Prior 2 years of study coordinator/clinical research coordinator experience is preferred.
- Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.
Clinical Research Associate in Sydney employer: Medpace
Medpace is an exceptional employer, offering a dynamic work environment in Melbourne that fosters professional growth and development within the clinical research field. With a strong focus on employee well-being, competitive compensation, and flexible working arrangements, Medpace supports its team members in achieving their career aspirations while contributing to meaningful advancements in medical therapeutics. Join a globally recognized leader in the CRO industry, where your expertise will be valued and your contributions will make a real impact.
