Clinical Research Associate – Remote Site Manager

MSD Australia & New Zealand; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive remuneration

Home or office based depending on your

Career growth Expand your expertise in

Professional development

Job summary

MSD Australia & New Zealand is seeking a Clinical Research Associate to ensure the performance and compliance of assigned protocols and sites in Australia. You will report to the CRA Manager and work to align study conduct with ICH-GCP, local regulations, company policies, quality standards, and adverse event reporting requirements.

You will act as the primary site contact and site manager across all study phases, helping grow the territory by developing new sites, sharing best practices and

Qualifications

• Associate degree, certificate, or equivalent in a scientific or healthcare discipline with relevant healthcare experience, including direct site management experience in a bio, pharma, or CRO environment, or a bachelor’s degree or above with direct site management experience in a bio, pharma, or CRO environment
• Strong understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and country clinical research laws and guidelines
• Working knowledge of Global and Country or Regional Clinical Research Guidelines
• Hands-on knowledge of Good Documentation Practices
• Proven site management capability, including site performance and patient recruitment
• Demonstrated monitoring capability and independent professional judgment
• Strong IT skills, including Microsoft Office and a range of clinical applications across computer, tablet, and mobile devices

Responsibilities

• Act as the primary site contact and site manager for allocated clinical research sites
• Develop and maintain strong site relationships throughout all phases of the trial
• Perform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documents
• Develop an in-depth understanding of the study protocol and associated procedures
• Coordinate and manage site readiness activities in collaboration with other sponsor functions
• Participate in site selection and site validation activities
• Conduct remote and on-site monitoring and oversight activities to ensure data integrity and subject safety
• Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits
• Prepare clear, comprehensive, and timely visit reports and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start‑up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance
• Identify, assess, and resolve site performance, quality, and compliance issues and elevate as required
• Work in partnership with internal and external stakeholders including country operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs or IECs, and regulatory authorities
• Maintain information and documentation accurately in CTMS, eTMF, and other relevant systems
• Contribute to CRA team knowledge by acting as a subject matter expert, buddy, or mentor and sharing best practices
• Support and/or lead audit and inspection activities as needed
• Perform co-monitoring visits where appropriate
• Identify and develop new potential sites in line with country strategy and support the development of strong clinical research capability

Skills

Site management

Monitoring

ICH-GCP

Regulatory documentation

Data integrity

Communication skills

Microsoft Office

Education

Bachelor's degree in a scientific or healthcare field

Associate degree or certificate in scientific discipline

Job description

MSD Australia & New Zealand is seeking a Clinical Research Associate to ensure the performance and compliance of assigned protocols and sites in Australia. You will report to the CRA Manager and work to align study conduct with ICH-GCP, local regulations, company policies, quality standards, and adverse event reporting requirements.

You will act as the primary site contact and site manager across all study phases, helping grow the territory by developing new sites, sharing best practices and