Address
Form of work
Salary- Multiple roles
- Flexible
- Full or Part time
Our client is an Australian owned company providing service excellence in the planning, design, initiation and management of human clinical trials and regulatory affairs services. They support their clients, based both locally and internationally, in the Biopharmaceutical and Medical Device industries. Their mission is to build partnerships with their clients in developing the next generation of therapeutics.
The opportunity
Due to growth, they are seeking to fill a number of roles across Australia. You maybe a CRA with only one years of experience or at can be at any level from CRA to SCRA. You may be based in any state across Australia.
Our client is exceptional in their offering of flexibility to their staff. They understand the need for flexibility in the workplace to ensure that their staff are engaged, successful, happy, and have their life/work balance right.
You will not be siloed into one function of only focusing on monitoring, rather you will gain experience across all aspects of the clinical trials program ensuring your own personal development and growth. In addition, you will:
- Collaborate with study team members for project execution.
- Assist in the development and review of study protocols and other study related documents.
- Perform site selection, initiation, monitoring and close-out visits and work with sites to adapt, drive and track subject recruitment plans.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Site set up, including assistance in preparation of Human Research Ethics Committee (HREC) and Site Governance submissions, preparation of regulatory packages, and essential document collection and management.
The experience
- Minimum 1 to 3 years plus prior experience monitoring clinical trials.
- Site monitoring experience from Phase I to Phase 4
- Tertiary qualifications in clinical or life sciences related fields.
- Demonstration of a solid knowledge of ICH-GCP, SAE and national & international regulations
- Leadership experience within a project team an advantage
- Excellent verbal and written communication and presentation skills.
- Able to work in a self-directed manner & identify issues and escalate with a plan for resolution.
The Offer
You will be given direct responsibility to contribute to the success of innovative, life changing products, where the outcomes will be recognised globally. All members of our client's team have direct impact on the continued growth of the business and exposure to an extensive range of products and therapeutic areas.
A flexible workplace that is diverse and inclusive, you will be privileged to be part of their progressive company.
The application
To join our client in this new and exciting opportunity, please email your cover letter & CV to Mark Thomas or Marilyn Jones at careers@mexec.com. Confidential enquiries to Mark or Marilyn on 1300 0 MEXEC
mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.
We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.
