Clinical Trial Specialist, Australia at Emerald Clinical Trials

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

16 Feb, 26

Salary

0.0

Posted On

18 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Regulatory Compliance, Data Entry, Document Management, Audit Preparation, Feasibility Assessment, Patient Recruitment, Team Collaboration, Medical Terminology, Quality Control, Informed Consent, Essential Document Preparation, Project Coordination, Communication Skills, Problem Solving, Organizational Skills

Industry

Biotechnology Research

Description

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. At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need. About the Role The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. The CTS works closely with project team to help manage clinical trial feasibility processes, coordinate clinical trial start-up activities including collection of essential documents for site initiation/startup, submissions to central IRBs/Ethic Committees, supporting site staff in the submission to local IRBs/Ethic Committees and changes to Informed Consent Forms (ICFs). Your Responsibilities Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project. Increase proficiency in uploading and maintaining TMF files and folders in Emerald Clinical’s file-sharing system by project as assigned Serve as second reviewer for TMF QC. May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight. Assist with/complete end of study TMF filing (including site close out documents), QC and archival. Further develop skills in preparing and participating in audit responses. Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables . Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned. Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned. Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable . Assist with presenting final feasibility results to PM team and/or Sponsor. Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs). Submit final EDPs to sponsor or CTM/PM as required About You College / University diploma / degree; OR at least 1 year related experiences and / or training; OR equivalent combination of education and experience. Ability to perform general administrative duties as needed or required. Exposure to medical terminology preferred. Knowledge of ICH/GCP, ethical and regulatory requirements preferred. Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise: Our 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. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience. • Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates.

Responsibilities

The Clinical Trial Specialist is responsible for supporting clinical trial activities, ensuring compliance with regulations and guidelines. They assist with site start-up activities, document management, and feasibility processes.