In-Demand Clinical trial Jobs in Sydney Nsw

Start-up Associate (Clinical Trial Associate) - Sydney
Fortrea —Sydney NSW
- Full-time
- Office
- Bachelor's degree
8d
Clinical Trial Coordinator
ICON Plc —Sydney NSW
- Full-time
- Management
- Administrative experience
- Bachelor's degree
- Health insurance
- Dental insurance
1d
Medical Oncology Clinical Trials Coordinator
Northern Sydney Local Health District —Sydney NSW
- $1,750.26 - $2,328.48 a week
- Full-time
- Microsoft Excel
- Microsoft Access
- Management
4d
Clinical Data & Laboratory Coordinator
GenesisCare —St Leonards NSW
- Part-time
- Laboratory experience
- Research
- Administrative experience
10d
Clinical Trial Coordinator
St Vincent's Health Australia —Inner West NSW
- $81,748.17 - $121,497.00 a year
- Full-time
- Data analysis skills
- Research
- No degree
Clinical Research Coordinator
Icon Group —Sydney NSW
- Part-time
- Research
- Administrative experience
- Bachelor's degree
- Parental leave
- Employee assistance program
Clinical Research Associate II
AbbVie —Sydney NSW
- Full-time
- Remote
- Patient monitoring
- Bachelor's degree
- Organisational skills
4d
Clinical Trial Study Coordinator-School of Public Health
University of Sydney —Camperdown NSW
- $117,133 a year
- Full-time
- Research
- University
- Budgeting
3d
Clinical Research Associate
ICON Plc —Sydney NSW
- Full-time
- Patient monitoring
- Bachelor's degree
- Communication skills
- Health insurance
- Dental insurance
1d
Research Assistant
GenesisCare —St Leonards NSW
- Full-time
- Research
- Microsoft Office
- Administrative experience
- Employee assistance program
Clinical Research Associate II
PSI CRO —Sydney NSW
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick Apply
Associate Manager/ Manager, Clinical Operations
Parexel —North Ryde NSW
- Management
- Patient monitoring
- Public speaking
8d
Regulatory and Study Start Up Clinical Trials
Chris O’Brien Lifehouse —Camperdown NSW
- Full-time
- Organisational skills
- Communication skills
- Negotiation
- Employee assistance program
8d
Project Support Associate x2
Southern Star Research —North Sydney NSW
- Full-time
- Hybrid work
- Research
- Microsoft Office
- Organisational skills
Quick Apply
Clinical Research Coordinator
GenesisCare —St Leonards NSW
- Part-time
- Vital signs
- Patient monitoring
- Research
14d
Clinical Trial Coordinator
St Vincent's Hospital Network —Sydney NSW
- $81,748.17 - $121,497.00 a year
- Full-time
- Data analysis skills
- Research
- No degree
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
9d
Pathology Collector
St Vincent's Health Australia —Inner West NSW
- $33.14 - $34.48 an hour
- Night shift
- Blood sampling
- Customer service
- Data entry
9d
Clinical Trial Nurse
KG Talent —Sydney NSW
- Full-time
- Nursing
- Research
- Bachelor's degree
Quick Apply

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Start-up Associate (Clinical Trial Associate) - Sydney

Fortrea -
Sydney NSW

Apply Now

Job Details

Full-time
8 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 .

Apply Now

Refine Your Search

clinical trial jobs in sydney nsw

Start-up Associate (Clinical Trial Associate) - Sydney

Clinical Trial Coordinator

Medical Oncology Clinical Trials Coordinator

Clinical Data & Laboratory Coordinator

Clinical Trial Coordinator

Clinical Research Coordinator

Clinical Research Associate II

Clinical Trial Study Coordinator-School of Public Health

Clinical Research Associate

Research Assistant

Clinical Research Associate II

Associate Manager/ Manager, Clinical Operations

Regulatory and Study Start Up Clinical Trials

Project Support Associate x2

Clinical Research Coordinator

Clinical Trial Coordinator

Clinical Research Associate

Clinical Trials Coordinator

Pathology Collector

Clinical Trial Nurse

I want to receive the latest job alert for clinical trial in sydney nsw

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