Senior Clinical Research Associate, Australia
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At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia‑Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post‑marketing.
Our therapeutic expertise spans renal, cardiometabolic, and oncology —areas where we make a significant impact on improving global health.
About the Role
The Senior Clinical Research Associate (SCRA) is a member of the Clinical Operations group at Emerald Clinical. The clinical operations group is responsible for site management, monitoring tasks, and operational support of clinical trials. The group allocates resources to projects as appropriate to implement project plans and ensure compliance with regulatory requirements and SOPs.
Responsibilities
* Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
* Complete all monitoring activities per the Monitoring Plan, including monitoring visit reports, accurately and within the predetermined timeframe.
* Prepare, plan, organise, and conduct site evaluation visits and report on these visits to assist with site selection.
* Prepare, submit, and liaise with regulatory specialist colleagues regarding preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
* Negotiate site budgets, coordinate site contract execution, track invoicing, and ensure timely site payments.
* Prepare, plan, organise, and conduct site initiation visits.
* Develop and maintain appropriate monitoring tools and project‑specific documents.
* Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and trial requirements so they can fulfill their obligations to conduct the trial accurately and within deadlines.
* Manage trial sites using both on‑site and off‑site activities including:
o Verification of quality, accuracy, completion, and timeliness of data.
o Ensure complete and efficient resolution of data queries, audits, issues, and liaise with Data Management and/or Quality colleagues, as needed.
o Adhere to the trial protocol, all applicable project‑related plans, training matrix, and other relevant project‑specific requirements.
o Adhere to ICH/GCP and other regulatory guidelines and requirements, reporting of subject safety, adverse/serious adverse events, protocol violations/deviations, and liaise with safety colleagues as needed.
o Ensure targets, metrics, and quality are maintained per trial expectations.
o Identify risks associated with clinical trial design, privacy, confidentiality, and misconduct, and take action to mitigate risk proactively and escalates as appropriate.
* Collect, review, and approve essential trial site documents, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
* Reconcile contents of in‑house TMF and site's Investigator Site Files.
* Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
* Maintain trial information using the clinical trial management system and other tracking and reporting tools for the trial.
* Support strategies to boost recruitment efforts.
* Coordinate and perform translation verification of regional language, as required.
* Perform site close‑out visits and other site activities including archiving, as applicable.
* Mentor, coach, and train junior staff members as directed by line management.
* Perform any additional responsibilities assigned by the Line Manager and/or Project Lead.
About You
* Educated to degree level in pharmacy, medical, nursing, biological science, or other health‑related disciplines; preferred or equivalent experience ≥5 years, but ≥4 years may be considered.
* Displays high competence in ethical and participant safety considerations, site start‑up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
* Demonstrates high competence in negotiation and conflict resolution, critical thinking, problem solving, decision making, and strategic thinking.
* Demonstrates solid interpersonal communication and presentation skills; is flexible and can work well within a multidisciplinary team both autonomously and with a wide range of stakeholders.
Why Join Us?
* Purpose‑Driven Work : Contribute to clinical trials that genuinely improve lives, focusing on therapies in renal, cardiometabolic, and oncology.
* Global Reach, Local Expertise : Teams connect with local communities, building trust and meaningful engagement for every trial.
* Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.
We are an equal‑opportunity employer and encourage applications from all qualified candidates.
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