Clinical Research Associate

Company Overview

QIAGEN is dedicated to driving innovations that improve life, advancing science and healthcare worldwide. With thousands of professionals across six continents, the company fosters collaboration and values diversity, continuously shaping the future of biological discovery.

About the Role

The Clinical Research Associate will join QIAGEN's Clinical Affairs team, playing a key role in advancing clinical evidence for diagnostic products. This position involves direct contribution to clinical studies that validate diagnostic technologies positively impacting patient care.

Key Responsibilities

• Support site selection, initiation, training, monitoring, and closure procedures for clinical studies.
• Coordinate processes related to ethics and regulatory submissions, contracts, and site activation.
• Organize instrument setup, operational qualification, and provide training for testing protocols.
• Manage study material forecasting, supply coordination, and maintain documentation under established procedures.
• Ensure timely data gathering, perform source data verification and review, resolve data queries, and assist with database verification and locking.
• Maintain accurate and updated Trial Master File documentation, review protocols, case report forms, and associated study documents.
• Participate in continuous improvement efforts to enhance clinical processes and documentation quality.

Candidate Profile

• Prior experience in clinical research or within pharmaceutical, medical device, or in vitro diagnostic sectors.
• Knowledge of clinical trial procedures, IVD studies, ICH-GCP guidelines, and regulatory standards.
• Scientific or medical background; experience in molecular biology or clinical diagnostics is a plus.
• Experience interacting with external study sites and operating in regulated environments.
• Exposure to audit preparations and participation.
• Strong communication, organizational skills, with the ability to work independently and collaboratively with multidisciplinary teams.
• Willingness to travel up to 30% as necessary.

Compensation and Benefits

The salary range for this position is estimated between $65,000 and $75,000 based on qualifications, experience, and location. The total remuneration package includes a bonus plan and comprehensive benefits such as local benefits, referral programs, volunteer days, internal training academy, employee assistance program, and conditional hybrid work options.

Diversity and Inclusion

QIAGEN fosters an inclusive workplace and is an equal opportunity employer, ensuring fair treatment without discrimination based on race, color, sex, age, nationality, religion, sexual orientation, gender identity, veteran status, or disability.