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(Contractor) Site Activation Partner - FSP (Study Start-Up Associate)
This is a fixed term contractor role until April ****.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 ****/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 roleClinical 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 ****/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 / inspectionsCommunication:+ 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 stakeholdersClinical 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, Valuable 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 issuesSubject 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/ systemsCompliance with Parexel standards:+ Complies with required training curriculum+ Completes timesheets accurately as required+ Submits expense reports as required+ Updates CV
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📌 Graduate Civil Engineer – Global Program & Mentorship (Gold Coast)
🏢 CSEA
📍 Gold Coast