Clinical Research Associate

Medpace; City of Brisbane; Sur place; AUD 70 000 - 100 000; Plein temps

Résumé du poste

Medpace in Australia is seeking a Clinical Research Monitor to conduct qualification, initiation, monitoring, and closeout visits in line with the approved protocol. You will communicate with site staff, verify resources, and ensure adherence to GCP, SOPs, and regulatory requirements.

Responsibilities include reviewing regulatory documents, drug accountability, adverse event reviews, and supporting site recruitment.

Qualifications

• Bachelor's degree in a health or science related field.
• 2 years of study coordinator/clinical research coordinator experience preferred.
• Knowledgeable about Clinical Monitoring practices and procedures.

Responsabilités

• Conduct qualification, initiation, monitoring, and closeout visits per protocol and regulatory requirements.
• Communicate with site staff including coordinators, physicians and staff.
• Verify investigator qualifications, training, facilities, and resources.
• Verify data against case report forms and ensure good documentation practices per SOPs, GCP and regulations.
• Ensure enrollment of only eligible subjects and review regulatory documents.
• Maintain investigational product accountability and inventory; review adverse events and related data.
• Assess site recruitment and retention; provide suggestions for improvement.
• Complete monitoring reports and follow-up letters with summaries and recommended actions.

Connaissances

Clinical monitoring experience

Regulatory knowledge

Communication skills

Formation

Bachelor's degree in health or science

Description du poste

• 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.

Qualifications:

• Bachelor's degree in a health or science related field;
• Prior 2 years of study coordinator/clinical research coordinator experience is preferred; and
• Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.