Clinical Research Associate
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.
Responsibilities
- Serving as the primary contact for clinical study sites, ensuring smooth study start-up, effective monitoring, and high-quality data collection in a regulated environment.
- Ensuring clinical research is conducted in accordance with applicable regulations and guidelines; reviewing data to confirm it meets acceptable clinical and regulatory standards; and protecting the rights, safety, and well-being of human subjects participating in clinical studies.
- Supporting site selection, initiation, training, monitoring, and close-out activities.
- Cooking up 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.
- 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.
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.
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.
Skills
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.
Benefits
The estimated base salary range for this position is $65,000-$75,000. Compensation will be based on the candidate’s experience, skills, geographic location, and other job-related factors.
In addition to base salary, we offer a total compensation package that includes a bonus plan and generous benefits.
Pay
The estimated base salary range for this position is $65,000-$75,000. Compensation will be based on the candidate’s experience, skills, geographic location, and other job-related factors.
Schedule
Hybrid work (conditional to your role)