Clinical Research Associate: Impactful Trial Monitoring

OPIS s.r.l.; Australia; On-site; AUD 90,000 - 130,000; Full time

Job summary

OPIS s.r.l. seeks a Clinical Research Associate to manage and monitor multi-country clinical trials in alignment with study protocols and ICH-GCP.

You will oversee site selection, initiation, monitoring, and close-out, ensuring data quality and patient safety while reporting to the Clinical Project Manager. Responsibilities include feasibility studies, site visits, data verification, adverse event reporting, and collaboration with sponsors and site staff.

Qualifications

• Degree in a scientific field.
• Minimum 2 years’ CRA or clinical trial monitoring experience.
• Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes.
• Good English and Microsoft Office skills.
• Strong organizational, communication, and problem-solving abilities.
• Ability to work independently and in a team.

Responsibilities

• Identify, assess, and initiate investigational sites.
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.
• Perform source data verification and ensure data accuracy and completeness.
• Monitor patient recruitment and support sites in meeting targets.
• Ensure proper reporting of adverse events and protocol deviations.
• Manage investigational product handling, storage, and accountability.
• Maintain study documentation (TMF/eTMF, Investigator Files).
• Write monitoring reports and follow-up communications.
• Collaborate with project teams, sponsors, and site staff.
• Support audits/inspections and mentor junior CRAs.

Skills

ICH-GCP knowledge

ISO14155

Clinical trial processes

English proficiency

MS Office

Organizational skills

Communication skills

Problem solving

Teamwork

Education

Degree in scientific field

Tools

Microsoft Office

Job description

OPIS s.r.l. seeks a Clinical Research Associate to manage and monitor multi-country clinical trials in alignment with study protocols and ICH-GCP.

You will oversee site selection, initiation, monitoring, and close-out, ensuring data quality and patient safety while reporting to the Clinical Project Manager. Responsibilities include feasibility studies, site visits, data verification, adverse event reporting, and collaboration with sponsors and site staff.