Assistant Clinical Research Associate (m/f/d)

About Thermo Fisher Scientific and PPD

Join Thermo Fisher Scientific in making a global impact by enabling healthier, cleaner, and safer communities through life-changing therapeutic research and development. As part of our PPD clinical research portfolio, our activities span laboratory, digital, and decentralized clinical trial services across 100+ countries. We foster a collaborative culture that values team effort, innovation, and career growth.

Role Overview

The Assistant Clinical Research Associate (CRA) will remotely manage and monitor assigned clinical trial sites, ensuring adherence to FDA and/or local regulations, ICH GCP guidelines, and company procedures. This position operates under a 2-year fixed-term contract with standard office hours from Monday to Friday.

Key Responsibilities

• Establish and maintain collaborative communication with site personnel discussing protocol execution, enrollment strategies, data queries, and site performance.
• Track and complete essential subject data reviews in electronic data capture (EDC) systems as per study requirements, raising manual queries when needed.
• Remotely examine study logs and conduct/manage site management calls in line with monitoring plans.
• Participate in investigator meetings and follow up on centralized monitoring findings.
• Assess principal investigator oversight, subject safety, and study conduct using risk-based monitoring approaches including root cause analysis and corrective action planning.
• Provide refresher training, assist with regulatory document updates and reviews upon request.
• Review clinical listings, track deviations and violations, enrollment, data completeness, and serious adverse event follow-up.
• Supply trial status updates and reports to study management teams.
• Coordinate investigator payments where applicable.
• Collaborate internally to gather required documents and review findings from various data sources.
• Support audit-ready file maintenance and ensure compliance with clinical trial management systems (CTMS) and electronic trial master file (eTMF) protocols.

Qualifications and Experience

• Bachelor’s degree in a life sciences field is required. Current PPD CRAs may qualify without this requirement.
• Between none and one year of clinical research experience or suitable knowledge gained through training or clinical environments.
• Aspiration to progress to a CRA role is preferred.
• Basic knowledge of medical terminology and therapeutic areas essential.
• Fluency in German and English at C1 or higher level.
• Proven ability to learn and apply clinical research guidelines, including ICH GCPs and internal procedures.
• Strong communication, interpersonal, organizational, and time-management skills.
• Demonstrated critical thinking, problem solving, and root cause analysis abilities.
• Comfortable working both independently and collaboratively in a team environment.
• Proficiency with MS Office and eagerness to use clinical research software and technology.

Additional Information

• Work schedule: Monday to Friday standard office hours.
• 2-year fixed-term employment contract.
• Work environment: office-based and remote collaboration.
• We value diversity and encourage applications from severely disabled candidates, who will be given preferential consideration on equal aptitude.
• Our corporate values emphasize Integrity, Innovation, Intensity, and Involvement.
• Thermo Fisher Scientific provides extensive opportunities for professional development, including award-winning training programs and a strong commitment to employee well-being and work-life balance.