Clinical Research Associate - In Vitro Diagnostics

Qiagen N.V; Manchester; On-site; GBP 30,000 - GBP 45,000; Full time

Job summary

A leading biomedical firm is seeking a Clinical Research Associate to support clinical studies with innovative diagnostic solutions. The role involves ensuring compliance with regulations, overseeing study site activities, and coordinating various processes for high-quality data collection. Ideal candidates will have a strong background in clinical research and excellent organizational skills. This position may require international travel up to 30%.

Qualifications

• Experience in Clinical Research or within the IVD industry.
• Understanding of ICH-GCP and regulatory requirements.
• Experience with external study sites in regulated environments.

Responsibilities

• Support site selection, initiation, training, and monitoring.
• Coordinate start-up processes including regulatory submissions.
• Ensure timely data collection and resolve data queries.

Skills

Experience in Clinical Research

Understanding of clinical trial processes

Strong communication skills

Organizational skills

Ability to work independently

Education

Scientific or medical education

Job description

Clinical Research Associate – In Vitro Diagnostics page is loaded## Clinical Research Associate – In Vitro Diagnosticsremote type: Onsitelocations: Manchester: Wroclaw: Barcelonatime type: Full timeposted on: Posted Todayjob requisition id: JR00000317**Overview**At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.At QIAGEN, every day is an opportunity to make a real-life impact.Join us, grow with us, and together, let's shape the future of biological discovery.ㅤ**About the opportunity**Join our Clinical Affairs team and help advance high-quality clinical evidence for QIAGEN’s innovative diagnostic solutions. You will contribute directly to studies that support the development and validation of diagnostic technologies with real-world impact on patient care.As Clinical Research Associate (CRA) you will act as the primary contact for clinical study sites, ensuring smooth study start‑up, effective monitoring and high‑quality data collection in a regulated environment. You will be responsible for ensuring clinical research is conducted in accordance with applicable regulations and guidelines; reviewing data to confirm it meets acceptable clinical and regulatory standards; as well as protecting the rights, safety, and well-being of human subjects participating in clinical studies.**Your tasks*** Supporting site selection, initiation, training, monitoring and close‑out activities.* Coordinating start‑up processes including IEC/IRB (Ethics Committee) and regulatory submissions, contracts and site activation activities.* Organising instrument set-up, operational qualification and training for testing procedures.* Managing study material forecasting, supply coordination and documentation according to Standard Operating Procedures.* Ensuring timely data collection and performing source data verification / Source Data Review, resolving data queries and supporting database verification and database lock.* Maintaining accurate documentation in the Trial Master File, ensuring timely upload, review and approval of study documents. Reviewing protocols, Case Report Forms and study documentation.* Contributing to continuous improvement initiatives by identifying opportunities to enhance clinical processes, documentation, and ways of working.**Your profile*** Experience in Clinical Research or within the pharmaceutical, medical device or In Vitro Diagnostic (IVD) industry.* Understanding of clinical trial processes, IVD studies, ICH‑GCP and regulatory requirements.* Scientific or medical education; experience in molecular biology or clinical diagnostics is an advantage.* Experience working with external study sites and within regulated environments.* Familiarity with audit preparation or participation.* Strong communication, documentation and organisational skills with an ability to work independently while collaborating effectively with cross-functional teams.* Willingness to travel internationally (up to 30%) as required.ㅤ**About QIAGEN**Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve.We inspire with our leadership and make an impact with our actions.We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.