An opening has arisen for a Clinical Research Associate to join TC BioPharm Ltd (TCB), an established, fast-growing immunotherapy company developing future cancer and infectious disease treatments. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Clinical Operations Manager. Our unique culture, values and working environment attracts, retains, and inspires people to give their best.”
The Clinical Research Associate will be responsible for the coordination of a variety of clinical trials in oncology and viral (cell immunotherapy) to ensure that trials are conducted in accordance with ICH GCP and other relevant regulatory guidelines, protecting the safety of participants and the quality of the data. The trials will be conducted in the UK, the European Union and North America.
The candidate will take ownership of assigned studies and carry out site selection/feasibility, support to EC/RA submissions, initiations, on-site monitoring, and close-out activities. Development opportunities into more senior roles within the company are available as the company expands.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- To ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework.
- Experience of performing site start up procedures, routine monitoring and site closure.
- Ability to manage multiple priorities across various clinical trials
- Establishing regular lines of communication plus administering protocol and related study training to assigned site
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- A Bachelor's degree in a health care or other scientific discipline or educational equivalent or nursing degree
- Alternatively, you should have an equivalent combination of education, training and experience
- Essential skills & experience:
- Must have at least 2 years of monitoring experience as CRA (oncology/viral required)
- Experience in site set up and regulatory and EC submissions in EU and US would be an advantage
- Experience in haematology, immunotherapy and/or cell therapy would be an advantage
- Thorough knowledge of ICH GCP and other industry-recognised standards and guidelines and conducting clinical trials in general.
- Excellent inter-personal, organisational, presentation and written communication skills
- Proactive approach with high levels of initiative, energy and commitment.
If you are passionate about immunotherapy and are looking to work within a challenging, dynamic, and rewarding environment, then TC BioPharm (TCB) represents an excellent career move.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary (reviewed annually), we offer a comprehensive range of benefits and an excellent working environment.