Job Description

Clinical Research Associate (CRA)

Permanent, full-time role with competitive remuneration and benefits

Location: Macquarie Park, Sydney, Australia - Home or office based depending on location

Career growth: Expand your expertise in a growing, successful industry

Professional development: Gain valuable experience in a dynamic, evolving role

As a Clinical Research Associate, you will be accountable for the performance and compliance of assigned protocols and sites within a country. Reporting to the CRA Manager, you will ensure study conduct aligns with ICH-GCP, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

This role acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. You will also contribute to territory growth by identifying and developing new sites, while sharing best practices and supporting monitoring capability within the wider CRA team.

Responsibilities include, however not limited to:

• 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 escalate 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

What You Must Have:

• 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
• Ability to interpret data and metrics and act appropriately
• Ability to manage complex issues in a solution-oriented manner
• Fluent in local language and English, with strong verbal and written communication skills
• Effective time management, organizational, interpersonal, problem-solving, and conflict management skills
• Ability to work highly independently across multiple protocols, sites, and therapy areas
• Strong accountability, urgency, and ability to manage multiple priorities in a changing environment
• Ability to work effectively in a matrix, multicultural environment
• Strong customer focus and professional demeanour
• Positive, self-driven, and growth-oriented mindset

What You Can Expect:

• The opportunity to own and influence assigned sites across a national clinical research portfolio
• Exposure to site management, monitoring, start-up, and close-out activities in a highly regulated environment
• The chance to help grow the clinical research territory by identifying and developing new sites
• A collaborative, matrixed environment where your expertise and judgement are valued
• Requires domestic and international travel approximately 65%-75% of working time

We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace.

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