Clinical Research Associate

QIAGEN•Germantown, TN

10d•Hybrid

About The Position

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.

Requirements

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 organizational skills with an ability to work independently while collaborating effectively with cross-functional teams.
Willingness to travel (up to 30%) as required.

Responsibilities

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.
Organizing 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.