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The role is covered in the following locations: Birmingham, Conventry, Dudley, Worcester, Walsall, Wolverhampton

Role Overview

Are you looking for an opportunity to join a market leader within immunodiagnostics as they launch an exciting and innovative new product to the market? Do you have experience working as a Clinical Research Associate?

If Yes - then we have a fantastic opportunity for you!

Title: Clinical Research Associate
Location: Birmingham (Hybrid Working)

We are looking for a Clinical Research Associate to join the Clinical Affairs team. This role will act as the main liaison between the Sponsor and the clinical site during in vitro diagnostic studies for the support of regulatory submissions. They will liaise with internal and external stakeholders for the management and conduct of clinical studies

This role requires up to 30% international travel.

Key Duties and Responsibilities

- Assist in developing clinical study protocols, informed consent forms, case report forms, clinical study reports and other relevant study documents as applicable.
- Oversee all aspects of clinical study conduct, from planning to clinical study report.
- Train study staff and ensure that the study is performed according to the approved protocol.
- Perform independent monitoring of study sites, including qualification, initiation, monitoring visits, and close-out visits.
- Maintain frequent contact with and work effectively with investigators and coordinators. Review and resolve discrepancies in clinical data with clinical sites.
- Coordinate with the ethics committee as needed to safeguard the rights, safety and wellbeing of all study subjects

Person Specification

The Ideal Candidate:
- Is a BSc in Biochemistry, Immunology, Regulatory Affairs or similar.
- Has relevant professional experience in the medical device industry, ideally in the in vitro diagnostics field.
- Certified Clinical Research Associate certification is desirable
- Understand the principles of analytical and clinical performance evaluation and relevant CLSI guidelines.
- Demonstrate strong organizational skills, including excellent record-keeping skills and good documentation practice.
- Has solid technical writing, oral communication and computer skills.
- Familiarity with the technology of immunoassay analysers and knowledge of the diagnostic immunology and haematology field are a plus.

01 Oct 2022

Maia D'Souza

Laboratory Recruiter 01494 818021

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