Clinical Research Associate at QIAGEN in Germantown

Summary: QIAGEN is dedicated to revolutionizing science and healthcare for the better. The Clinical Research Associate 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. 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 Required Qualifications: - 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 Required Skills: Clinical Research, Pharmaceutical Industry, Medical Device Industry, Vitro Diagnostic (IVD) Industry, Clinical Trial Processes, ICH-GCP, Regulatory Requirements, Molecular Biology, Clinical Diagnostics, Audit Preparation, Trial Master File Management, Source Data Verification, Case Report Forms Benefits: Bonus/Commission, Local benefits, Referral Program, Volunteer Day, Internal Academy (QIALearn), Employee Assistance Program, Hybrid work (conditional to your role)