In-Demand Start up associate (clinical trial associate) sydney Jobs in Sydney, Nsw

Start-up Associate (Clinical Trial Associate) - Sydney
Fortrea —Sydney NSW
- Full-time
- Office
- Bachelor's degree
12d
Clinical Research Associate
IQVIA —Sydney NSW
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Health insurance
Clinical Trials Coordinator
MSD —Macquarie Park NSW
- Full-time
- Microsoft Excel
- English
- Microsoft Office
13d
Senior / Clinical Research Associate
IQVIA —North Sydney NSW
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Senior Manager, Study Site Engagement
Takeda Pharmaceutical —Sydney NSW
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
13d

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Start-up Associate (Clinical Trial Associate) - Sydney

Fortrea -
Sydney NSW

Apply Now

Job Details

Full-time
12 days ago

Qualifications

Bachelor's degree
Clinical trials

Full Job Description

Job Overview:

Primary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.

Summary of Responsibilities:

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 Fortrea 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).

In Country specific tasks (Global):

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 Fortrea 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.
All other duties as needed or assigned.

Qualifications (Minimum Required):

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
Demonstrated basic understanding of the clinical trial process.

Physical Demands/Work Environment:

General Office Environment.

Learn more about our EEO & Accommodations request here .

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Start-up Associate (Clinical Trial Associate) - Sydney

Clinical Research Associate

Clinical Trials Coordinator

Senior / Clinical Research Associate

Senior Manager, Study Site Engagement

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