Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Clinical Research Associate based in Australia.
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As a Senior Clinical Research Associate, you will independently oversee clinical site monitoring and management activities across assigned clinical studies.
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You'll serve as a key link between sponsors, investigative sites, and cross-functional study teams, helping ensure studies are conducted safely, accurately, and in compliance with applicable requirements.
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The role spans site monitoring, recruitment and activation, study documentation, regulatory compliance, and ongoing site support.
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You'll work closely with investigators and site staff to maintain data quality, resolve issues, and keep studies aligned with timelines and milestones.
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You'll also contribute your expertise by mentoring junior CRAs and supporting quality, process improvement, and assessment activities.
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The position offers a home-based working environment with regular travel to clinical sites and study-related meetings.
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This is an opportunity to make a meaningful contribution to clinical research while working in a collaborative, accountable, and results-driven environment.
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Accountabilities
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Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits.
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Ensure all monitoring activities are performed and documented according to applicable SOPs, study plans, protocols, ICH-GCP guidelines, and local regulatory requirements.
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Review study data against source documentation to verify accuracy, completeness, consistency, and compliance with study requirements.
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Monitor, resolve, and facilitate the resolution of data queries, escalating significant issues appropriately.
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Coordinate the shipment and delivery of clinical supplies, including investigational products, laboratory materials, ePRO equipment, and study documentation.
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Train and support site staff on study protocols, systems, study plans, ICH-GCP requirements, and other applicable procedures.
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Act as a primary point of contact for investigative sites, addressing questions and coordinating timely resolution of site-related issues.
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Maintain oversight of study and site integrity while developing effective working relationships with investigators, site staff, sponsors, and internal study teams.
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Monitor site compliance with required training and provide support with access to relevant study systems.
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Track action items, protocol deviations,



outstanding issues, and corrective actions through to resolution.
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Coordinate ongoing study communications with investigative sites, ensuring teams receive accurate and timely updates regarding study objectives, regulatory requirements, processes, and project developments.
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Routinely review EDC, IRT, eTMF, CTMS, and other study systems to ensure accuracy, completeness, and compliance.
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Review and maintain Investigator Site Files and Trial Master Files, requesting missing or outstanding documentation when necessary.
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Support document translation, localization, and filing requirements as applicable.
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Participate in study progress meetings, teleconferences, investigator meetings, audits, inspections, and required follow-up activities.
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Support investigator and site selection by conducting and documenting qualification activities and advising on site suitability.
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Lead site activation activities and work with sites to meet study timelines, recruitment objectives, and key milestones.
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Support study start-up and regulatory teams by following up on pending documentation and reviewing or localizing site materials as required.
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Provide guidance to sites to optimize patient recruitment and achieve recruitment milestones.
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Mentor and support CRA I and CRA II team members, including participation in co-monitoring, assessment visits, and visit sign-off activities.
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Provide constructive feedback to junior CRAs and contribute to their professional development.
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Participate in interviews for CRA candidates when requested.
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Contribute to process improvement initiatives, best-practice development, and other internal initiatives.
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Requirements:
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4–6 years of relevant clinical research experience required, with 7–9 years preferred.
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Bachelor's degree, preferably with Honors, in Health Sciences, Life Sciences, Pharmacy, Nursing, or a related discipline; a Master's degree is advantageous.
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Relevant Senior CRA and/or ACRP certification or designation is a plus.
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Strong knowledge of ICH-GCP guidelines and applicable local regulatory requirements.
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Experience supporting Phase I–IV clinical trials is preferred.
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Proficiency with clinical research technologies and systems such as EDC platforms, including Medidata Rave or Oracle InForm, as well as IRT, eTMF, CTMS, and Microsoft Office.
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Demonstrated experience independently conducting site monitoring and site management activities across the clinical trial lifecycle.
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Strong understanding of clinical site operations, documentation requirements, data quality, study protocols, and regulatory compliance.
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Excellent interpersonal and communication skills, with the ability to build productive relationships with investigators, site teams, sponsors, and cross-functional stakeholders.
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Strong problem-solving skills and the ability to identify, manage, escalates, and resolve site-level issues effectively.
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Highly organized, detail-oriented, and capable of managing multiple priorities while maintaining a strong sense of urgency.
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Ability to work independently while also contributing effectively within cross-functional study teams.
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Fluent written and spoken English.
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Valid driver's license.
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Willingness and ability to travel approximately *****%, depending on project requirements and site locations.
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Comfortable working from a home-based environment while maintaining strong communication and accountability across distributed teams.
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Benefits:
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Salary: $58,000–$96,500 per year, depending on experience, qualifications, location, and other applicable factors.
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Home-based work: Work primarily from a home-based environment.
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Skilled growth: Opportunity to expand clinical research expertise across different study phases and therapeutic environments.
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Mentoring opportunities: Develop leadership skills by mentoring and supporting junior CRA professionals.
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Clinical trial exposure: Gain broad experience across site monitoring, study start-up, recruitment, regulatory activities, and study management.
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Cross-functional collaboration: Work closely with sponsors, investigators, regulatory teams, study start-up teams, and other clinical research professionals.
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Meaningful impact: Contribute directly to the quality, compliance, and successful execution of clinical research studies.
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Career development: Participate in process improvement initiatives and contribute to best practices across clinical research operations.
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Travel opportunities: Regular travel provides exposure to diverse clinical sites and study environments.
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Flexible working environment: Home-based role designed to support independent work alongside regular collaboration with distributed teams.
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📌 Sr. Clinical Research Associate (South Australia)
🏢 Jobgether
📍 South Australia