Location
Hybrid - Welwyn Garden City
Contract
: Fixed Term Contract (12 Months) - Full time
Salary
: £30,000 - £40,000 per annum
Benefits
: Private healthcare, pension, income protection, life assurance, 27 days holiday + bank holidays, equity scheme
Amber Therapeutics are looking for a Graduate Clinical Affairs Associate to make a real impact on patients' lives as we develop a fully adaptive neuromodulation therapy to treat mixed urinary incontinence. This is a 12-month fixed-term contract with potential scope for a permanent role, to work in a hybrid full-time role based between your UK home address and our Welwyn Garden City site.
The Role
An exciting opportunity to work in a new role coordinating activity related to deep brain stimulation external studies which are sponsored by academic collaborators. This will include liaising with hospital and university teams, as well as internal departments. This includes coordinating the provision of medical devices for clinical trials, repair and replacement of damaged external device accessories, reporting of complaints and adverse events and creation of documents such as Investigator Brochures and Risk Management files.
Key Responsibilities:
- Primary contact for external sponsors utilising Amber devices in their clinical trials.
- Coordinate supply of Amber devices with the Amber Manufacturing Team and external sponsors/clinical trial sites.
- Arrange shipment of clinical trial products
- Ensure device accountability is maintained from a manufacturer perspective for devices
- Arrange repair and replacement of damaged or defective device accessories
- Coordinate the completion of Investigator Brochures and other documentation
- Coordinate risk assessments and risk management updates to supporting documents for implantable medical devices and external accessories
- Aid in the preparation of Competent Authority and Ethics Board submissions
- Coordinate on site Clinical Operations Support for clinical trials run by external sponsors
- Additional related duties may at times include taking calls on evenings/weekends for time-sensitive patient case reviews and customer needs
- Reporting of Complaints and Adverse Events occurring in external sponsored Clinical Trials.
Essential Skills & Experience
- Bachelor's degree in a scientific, medical engineering or health-related field.
- Excellent written and oral communications skills.
- Experience of working as part of a multi-disciplinary team
- Knowledge of Clinical Research
Desirable Skills & Experience:
- Experience in Clinical Operations/Clinical Research/Clinical Trials environment.
- Knowledge of GCP and ISO14155
This role requires the ability to work on multiple projects in a fast-paced environment as well as excellent verbal and written communication skills. With strong organisational and prioritisation skills, you should have the ability to foster strong relationships with internal and external stakeholders.
What We Offer
This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays). Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.
You may have experience of the following: Science Lab Technician, Laboratory Technician, Lab Works, Laboratory Works, Trainee Lab technician. Clinical Research Assistant, Clinical Research Associate etc
Closing date 13-12-2024
REF-218079