Clinical Research Associate (CRA) - sponsor dedicated

Pharmaceutical Research Associates, Inc; Deutschland; Vor Ort; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

Join a forward-thinking clinical research organization where you will play a crucial role in shaping the future of clinical development. As a Clinical Research Associate, you will work alongside a dedicated team to monitor and manage clinical trials, ensuring compliance with regulations and guidelines. This position offers a unique opportunity to collaborate with a pharmaceutical company focused on developing life-saving treatments. Enjoy a supportive environment that encourages professional growth while making a significant impact on patients' lives. If you are passionate about clinical research and thrive in a dynamic setting, this role is perfect for you.

Leistungen

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifikationen

• 12+ months of CRA monitoring experience in clinical trials.
• Strong knowledge of ICH-GCP guidelines and medical data evaluation.

Aufgaben

• Set up and monitor studies, complete reports, and maintain documentation.
• Submit protocol and consent documents for ethics/IRB approval.

Kenntnisse

Monitoring experience in phase I-III trials

Knowledge of ICH-GCP guidelines

Excellent written and verbal communication

Ability to work to tight deadlines

Ability to travel (60% of the time)

Ausbildung

Degree in medicine or science

Jobbeschreibung

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people’s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

Responsibilities

What you will be doing:

• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
• Balancing sponsor generated queries
• Taking responsibility for study cost efficiency
• Preparation and review of study documentation and feasibility studies for new proposals
• Potential to assist in training and mentoring fellow CRAs

Qualifications

You have:

• 12 months+ of monitoring experience in phase I-III trials as a CRA
• Degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication in both English and German
• Ability to work to tight deadlines
• Availability to travel least 60% of the time (international and domestic - fly and drive) and should possess a valid driving license

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.