Senior Clinical Research Associate, Australia
Join the role of Senior Clinical Research Associate at Emerald Clinical.
This position supports the Clinical Operations group in site management, monitoring tasks, and the operational support of clinical trials across all phases.
About the Company
At Emerald Clinical Trials, we provide global, full-service Contract Research Organization (CRO) services with a strong heritage in the Asia-Pacific region.
We advance clinical research through scientific expertise and operational excellence for biopharmaceutical, medical device, and diagnostic customers, spanning renal, cardiometabolic, and oncology therapeutic areas.
About the Role
The Senior Clinical Research Associate (SCRA) contributes to site assessment, monitoring, regulatory compliance, and overall trial execution, ensuring adherence to regulatory requirements and Standard Operating Procedures.
Responsibilities
Coordinate investigator identification, feasibility assessment, and site selection.
Perform monitoring activities per the Monitoring Plan, completing monitoring visit reports accurately and on schedule.
Organise site evaluation visits and report findings to support site selection.
Prepare, submit, and liaise with regulatory specialists on regulatory packages, importation/exportation requirements, and Ethics Committee updates.
Negotiate site budgets, facilitate contract execution, track invoicing, and ensure timely site payments.
Conduct site initiation visits and maintain monitoring tools and project-specific documents.
Train and motivate investigators to ensure understanding of protocol, product, and trial requirements.
Manage trial sites using both on-site and off-site activities, including:
Verification of data quality, accuracy, completion, and timeliness.
Resolution of data queries, audits, and issues in coordination with Data Management and Quality teams.
Adherence to trial protocol, training matrices, and regulatory guidelines, including reporting of safety events and protocol deviations.
Maintaining target metrics and quality standards per trial expectations.
Identification and proactive mitigation of risks related to trial design, privacy, confidentiality, and misconduct.
Collect, review, approve essential documents, and code for Trial Master File (TMF) filing.
Reconcile contents between in-house TMF and site Investigator Site Files.
Coordinate distribution, tracking, handling, and destruction of investigational product and supplies per site/trial requirements.
Maintain trial information within the clinical trial management system and other reporting tools.
Support recruitment strategies and coordinate regional language translation verification as required.
Perform site close-out visits and associated activities, including archiving.
Mentor and coach junior staff members as directed by line management.
Carry out any additional responsibilities assigned by the Line Manager or Project Lead.
Qualifications
Degree in pharmacy, medicine, nursing, biological science, or related health discipline; minimum 5 years of clinical trial monitoring/supervision experience (4 years may be considered).
Knowledge of academic, CRO, or pharmaceutical environments preferred.
High competence in ethical and participant-safety considerations, site start-up, site conduct, risk and quality management, supply management, scientific concepts, clinical research design, and issue escalation.
Proven skills in negotiation, conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.
Strong interpersonal communication and presentation skills; adaptable and capable of working independently and within multidisciplinary teams.
Why Join Us?
Purpose-Driven Work: Contribute to trials that improve lives across renal, cardiometabolic, and oncology therapeutic areas.
Global Reach, Local Expertise: Engage local communities, build trust, and ensure diverse, representative patient recruitment.
Collaboration and Innovation: Thrive in a culture that values diverse perspectives and creative solutions to global health challenges.
We are an equal-opportunity employer and encourage applications from all qualified candidates.
Interested?
Apply now and help us achieve our mission to improve the health of millions worldwide.
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