Clinical Research Associate 1 (m/w/d), Single Sponsor

IQVIA; Deutschland; Remote; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A global contract research organization is seeking a Clinical Research Associate 1 to work home-based throughout Germany. This role involves site monitoring, collaboration with study experts, and ensuring compliance with clinical guidelines. Candidates should possess a relevant university degree, on-site monitoring experience, and fluency in German at C1. The position offers resources for career growth, flexible work schedules, and more.

Leistungen

Home-office

Company car

Accident insurance

Career growth resources

Qualifikationen

• University degree in life science or health care field.
• Minimum one year of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Fluency in German at C1 level.

Aufgaben

• Perform site selection, initiation, monitoring and close-out visits.
• Support the development of a subject recruitment plan.
• Evaluate the quality of site practices per GCP and ICH guidelines.
• Manage regulatory submissions and recruitment tracking.
• Collaborate with experts at study sites.

Kenntnisse

On-site monitoring experience

Communication skills

Attention to detail

Fluency in German (C1)

Good command of English

Ausbildung

University Degree in life science or related discipline

Jobbeschreibung

Overview

Join IQVIA as a Clinical Research Associate 1 / CRA 1 and work home-based throughout Germany in our single sponsor department.

You will enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients.

Whether you're just starting out or looking to deepen your expertise, this role promises to offer intentional career growth and professional development. With access to world-class training and mentoring, you’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Responsibilities

• Performing site selection, initiation, monitoring and close-out visits
• Supporting the development of a subject recruitment plan
• Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborating with experts at study sites and with client representatives
• Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices)
• Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included

Qualifications

• University Degree in life science or other scientific discipline or apprenticeship in the health care field
• Minimum of one year of on-site monitoring experience or an equivalent combination of education, training and experience
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment
• Fluency in German on at least C1 level and a good command of English
• Flexibility to travel up to 40-60% of working time
• Driver’s license class B

What you can expect

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences
• Home-office, company car, accident insurance and more

Whatever your career goals, we are here to ensure you get there!

Please apply with your English CV and motivation letter as well as your education certificates and job reference letter (Arbeitszeugnisse).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com