£Competitive, Cheshire, UK
Boyds is looking to hire an experienced, enthusiastic and motivated Clinical Research Associate to join us and support the future growth of our busy clinical and regulatory consultancy, working across a range of product types and therapeutic indications.
In this role, you will use your existing skills and knowledge to to explore the research field, and be part of a dedicated team bringing medicines to market for the benefit of patients.
- Perform qualification, initiation, monitoring, and closeout visits for study sites in the UK in compliance with approved study documentation
- Serve as the primary contact for communication with the site staff including study/data coordinators, clinical research physicians and other members of the study team at the sites
- Ensure thorough documentation is provided for investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Perform source data verification of medical records and source documentation against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
- Review of subject eligibility and screening data to ensure that investigators are enrolling eligible subjects
- Preparation and management of Ethics Committee submissions
- Review of investigational product/drug accountability
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions
- Assist the Clinical Operations team with the set up and management of feasibility studies
- Provide ongoing, flexible support to the Clinical Operations team, as and when required
REQUIRED QUALIFICATIONS AND EXPERIENCE:
- Minimum of a bachelor’s degree; Health or life science related field preferred
- At least 3 years of proven CRA experience
- Willing to travel within the UK, as required
- Familiarity with Microsoft® Office
- Strong communication and presentation skills
In return, we can offer an opportunity to work with a team with significant experience in developing groundbreaking ATMP (including gene therapies), biological and small molecule therapies for a range of conditions, many of which are in the rare disease and oncology therapy areas . We are a small, friendly, efficient and effective team and can help you to grow your future career in a professional and varied environment.
Boyds is a fast-growing consultancy business providing a range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Based in the UK with offices in Cheshire, Cambridgeshire and Dublin, Boyds has an international client base comprising of early stage life science and medical device companies as well as Universities.
Boyds has earned a reputation for its work in advanced therapies and in 2018, the company was awarded the prestigious Queen’s Award for Enterprise, International Trade for outstanding short-term growth in overseas sales.
We currently have vacancies in the clinical operations team, however we are always interested to hear from experienced individuals that are looking to develop their career with Boyds.
If you are interested in joining us, please send your CV and a short description of why you enjoy working in regulatory affairs and the difference you believe you could make for our clients to firstname.lastname@example.org.
No agencies please.