Description
At IQVIA, our Clinical Functional Service Partnership (CFSP) model offers the best of both worlds: the variety and sponsor-level exposure of working as an embedded member of a leading pharmaceutical or biotechnology team, backed by the stability, global infrastructure, and career support of IQVIA.
As a Trainee Clinical Research Associate / Associate CRA (m/w/d), you'll work across innovative studies and therapeutic areas, build your reputation with leading pharmaceutical and biotechnology partners, and grow your skills through structured training, mentorship, and genuine global career pathways.
Key Responsibilities:
- Complete therapeutic area, protocol-specific, and clinical research training required to perform assigned responsibilities.
- Gain practical experience in study conduct and site management through collaboration with experienced clinical research professionals.
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
- Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
- Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
- Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
- Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
- Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications.
- Identify, assess, and appropriately escalate study risks, site issues, and quality concerns while driving timely resolution.
- Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.
What you'll bring:
- University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
- Completed advanced training in clinical research with 2-6 month duration is mandatory.
- Good knowledge of clinical trial processes, Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Excellent communication, organizational, and stakeholder management skills.
- Fluent written and verbal communication skills in German language (minimum C1 level), along with a strong command of English.
- Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams.
- Willingness to travel within the assigned region (up to 40-60% of working time). A valid Class B driver's license.
- Home-office location throughout Germany (preference is North-Rhin-Westphalia, the Hamburg area, or the Frankfurt area).
- Availability to start on 16.Nov. or 1.Dec. 2026 is mandatory.
What you can expect:
- Permanent employment contract.
- In-depth training on the job, mentoring and co-monitoring.
- Home-Office in Germany and flexible working schedule.
- Company car or car allowance, accident insurance and more.