Start Up Specialist

1 week ago

Melbourne, Victoria, Australia Labcorp Full time

Develop awareness of regulatory legislation, guidance and practice in the assigned countries with the support from senior staff

? Assist senior staff to compile, prepare, submit and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements

? Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable)

? Perform a review of final submission documents as applicable

? Organize communication related to the submissions/outcomes within Labcorp as applicable

? Escalate study issues appropriately and in a timely fashion

? Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable)
? Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
? Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance
? Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
? Update study documents when there are changes in study personnel/study amendments
? Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp ready for an audit at any time
? Update status reports, applicable logs and tracking systems as applicable for the projects with input provided by senior staff
? With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements
? May support / assist the contract negotiation process under supervision of an experienced colleague or line manager
? Proactively identifying and escalating to Submission Leads any risk to meeting deliverables
? Notify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists

**Labcorp is proud to be an Equal Opportunity Employer**:
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