Senior Study Start up Submissions Coordinator
BH-225136-1
Posted: 20/11/2023
- Competitive total compensation & benefits package
- Australia Victoria Melbourne
- Permanent
-
Life Sciences
Senior Study Start Up Submissions Coordinator
This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.
The role
Required
On offer
Enjoy a competitive total compensation and benefits package and internal growth opportunities.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
- Global CRO – be part of something impacting millions of people
- Located: Melbourne
- Competitive total compensation & benefits package
- Flexible work arrangements available
- Internal growth opportunities
This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.
The role
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare, review, and submit to Regulatory Agencies;
- Communicate with global study teams and personnel on study progress;
- Ability to effectively identify risks to site activations and mitigate as necessary;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submission-related activities;
- Direct contact with investigative sites during the study start up and activation process;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements;
- Track submissions and ensure timely filing of documents.
Required
- A positive can-do attitude.
- Bachelors degree or higher in a scientific or healthcare discipline.
- 4+ years industry experience at a CRO, Pharma, Biotech or investigative site;
- Experience in preparing and submitting TGA regulatory applications;
- Excellent organization and communication skills;
- Knowledge of ICH - GCP guidelines and regulatory guidelines in Australia and New Zealand;
- Hands-on experience preparing, reviewing, and submitting regulatory documentation
- Proactive approach to role with ability and willingness to learn and be challenged.
- Full unrestricted working rights in Australia.
On offer
Enjoy a competitive total compensation and benefits package and internal growth opportunities.
- Competitive total compensation and benefits package.
- Flexible work arrangements (e.g., flex scheduling, remote working where applicable, etc.)
- Internal growth opportunities.
- Accelerated, tailored training program.
- Become part of a team dedicated to supporting the development of ground-breaking drugs and devices.
- On-site fitness center(s), restaurants, banks & campus walking paths
- Company-sponsored social and wellness events
- Free and covered parking
- Discounts for local businesses
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.