Clinical Research Associate II – Swansea, UK
Office-based or Remote-based
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Clinical Research Associate II / Senior Clinical Research Associate is responsible for the monitoring of clinical trials and tracking of study progress, thereby contributing to the overall management of clinical trials in accordance with the appropriate quality standards including ICH-GCP guidelines, Standard Operating Procedures (SOPs), applicable regulations, rules and guidance. S/he is responsible for clinical site start-up, maintenance, and closure activities, including maintenance of study documents. *Note, the Clinical Research Associate II / Senior Clinical Research Associate level will be determined based upon individual experience.
Specific tasks would include:
- Responsible for the monitoring of clinical trials throughout the UK and tracking study progress for our clients
- Interface with the Synteract study team to ensure timely initiation and completion of clinical trials
- Collect study related data and assist with the preparation, review and submission of regulatory documents to regulatory authorities
- Contribute to the overall management of trials in accordance with ICH-GCP standards, local requirements and SOPs
- Start-up, maintenance and closure activities of clinical studies including the maintenance of the TMF and study documentation
- Degree in life science
- 2+ years experience as a CRA
- Good scientific knowledge and understanding of clinical trials
- Good ICH-GCP knowledge and legal regulatory requirements
- Motivated, dedicated and service orientated approach
- Distinctive organizational skills, good time management and ability to meet deadlines
- Very good English skills (verbal and written), IT proficiency
- Willingness to travel
If you’re passionate about bringing clinical trials to life, we encourage you to apply today! Please apply online stating your earliest start date/notice period and your desired salary. If you have any questions regarding your application please contact Livia.Anstey@synteract.com.