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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 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 ****/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, Positive 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
#J-*****-Ljbffr

📌 Graduate Civil Engineer – Global Program & Mentorship (Adelaide)
🏢 CSEA
📍 Adelaide