Graduate Civil Engineer – Global Program & Mentorship

Csea; Australia; Remote; AUD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Site Activation Partner - FSP (Study Start-Up Associate) for a fixed-term contractor role through April 2027. The position allows full remote work and involves coordinating site activation activities, regulatory submissions, and life-cycle study documentation across multiple countries.

Key responsibilities include preparing IIP submissions, IRB interactions, TMF updates, and ensuring timely communication with investigators and study teams.

Qualifications

• Experience with site activation and regulatory submissions.
• Ability to coordinate with IRB/ethics committees and regulatory bodies.
• Strong cross-functional collaboration across study teams.

Responsibilities

• Initiate and coordinate site activation activities and essential documents.
• Manage regulatory submissions (IRB/ethics approvals, FDA forms) within required timelines.
• Coordinate with cross-functional teams to ensure site readiness and study compliance.
• Maintain TMF documentation and study records accuracy.

Skills

Site activation

Regulatory submissions

IRB/Ethics coordination

Cross-functional coordination

SIP platform

Tools

Shared Investigator Platform (SIP)

Trial Master File (TMF) systems

Job description

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(Contractor) Site Activation Partner - FSP (Study Start-Up Associate)

This is a fixed term contractor role until April 2027.
The role can be fully remote and open to consider site level start up activities experienced candidates who are interested in career experience in global CRO.
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