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- FSP (Study Start-Up Associate) Primary

Location:
Australia, Remote Job ID R0000047356 Category Clinical Trials Date Posted 10/23/2026 Apply Now
• Success profile
• About this role
• Potential career path
• Employee insights
• Our team
• Why Clinical Research Associates work at Parexel
• Learn about our culture Overview As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally. Success Profile Do you have these soft skills and interpersonal traits to succeed at Parexel?
• Communicator
• Detail-oriented
• Flexible
• Organized
• Problem-solver
• Self-starter Back to nav About This Role External

Job Description
Key Accountabilities Clinical Trial Site Activation:
• Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site initiation
• Provide support to resolve issues or concerns and timely escalation of site issues where applicable
• Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements
• Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval (country dependent)
• Support investigators sites with local IRB workflow from preparation, submission through approval
• Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures
• Support and implement activities in Shared Investigator Platform (SIP) to align with the client’s strategy as it relates to the role Clinical Trials Conduct
• Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct
• Ensure maintenance of IRB/Ethics and other committees’ activities as applicable
• Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections Communication
• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
• Provide functional updates on a country and site level as required
• Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
• Disseminate central or local ethics approval to study team and Investigator sites where applicable
• Communicate local sites approvals to study team members and stakeholders Clinical Trial Site Support
• As needed, perform,



awareness session with site personnel on client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and client standards
• Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues Subject Matter Expert (SME)
• A good understanding of the site activation requirements and processes within the country/region and be able to learn and potentially implement in more than one country
• May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multiple countries
• May be assigned as an SME on a system and/or process, and represent the SAP function as applicable
• May represent the SAP role on global initiatives
• Able to act as an SME on projects and initiatives, as requested
• Support the mentoring of new hires on processes/ systems Compliance With Parexel Standards
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills
• Knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details
• Understand the quality expectations and emphasis on right first time
• Compliance with all applicable company, regulatory and country requirements
• Attention to detail evident in a disciplined approach
• Ability to work independently and also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations
• Ability to use and learn systems, and to use independently
• Microsoft Suite o Clinical Trial Management Systems (CTMS)
• Electronic Trial Master File o Electronic Investigator Site File (e.g. Florence)
• Document exchange portals o Shared Investigator Platform o Ethics, National Networks and Governing Bodies Portals and platforms (as needed)
• Flexible and adapt to off

working hours
in a global environment (when applicable)
• Able to travel as needed, including some international travel possible Knowledge And Experience
• Experience working in the pharmaceutical industry/or CRO in study site activation preferred
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in local language and in English. Multilanguage capability is preferred
• Individuals based in Canada: Bilingualism (French, English) is preferred
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems Education
• School diploma or certificate with equivalent combination of education, training and experience or Bachelor of Science or Bachelor of Arts or equivalent
• Education in life sciences discipline is preferred
• Minimum 2 years relevant experience in clinical site management Back to nav Share this job
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• Email Potential Career Path Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
• APEX CRA
• CRA I
• CRA II
• Senior CRA
• Project Management Subject Matter Expert People Management Back to nav Employee Insights Nick on a day in the life of a CRA Nick Burger | Senior Clinical Research Associate Watch Video Liliana on CRA tasks and our recognition program Liliana Belmares Flores | CRA Line Manager Watch Video Marlayna on why Parexel is a excellent place for CRAs Marlayna Fitts | CRA Line Manager Watch Video Back to nav TEAM IMPRESSIONS Back to nav Why Clinical Research Associates work at Parexel Patient-focused in everything we do We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused Supportive and inclusive environment We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals. Career growth and development We develop your skills through training, mentorship, and career advancement programs. Flexible work arrangements We focus on outputs and results, not where and when you work. Diverse therapeutic areas and project exposure We continuously learn from a broad exposure from early to late phase clinical trials and our cros-functional global teams. Advanced Technology We recognize the importance of first-time quality to bring treatments to patients faster. Back to nav Learn About Our Culture Back to nav Back to nav
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📌 Site Activation Partner (Perth)
🏢 ATLAS MEDICAL SERVICES LTD. STI.
📍 Perth