Clinical Research Associate (CRA)

Aus - New South Wales - Macquarie Parkmid

HealthcareClinical Researcher

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Quick Summary

Requirements Summary

Act as the primary site contact and site manager for allocated clinical resea

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HealthcareClinical Researcher

Job Description

Responsibilities

~2 min read

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

Requirements

~1 min read

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
Ability to perform root cause analysis and implement corrective and preventive actions
Fluent in local language and English, with strong verbal and written communication skills
Effective time management, organisational, 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

25%

The opportunity to own and influence assigned sites across a national clinical research portfolio

Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Documentation, Data Reporting, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset