Assistant CRA - FSP (m/f/d)

Thermo Fisher Scientific GmbH; Deutschland; Remote; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Full-time (40 hours/week)

Flexible working models

Job summary

Thermo Fisher Scientific GmbH is seeking an Assistant CRA to support remote site management and monitoring on assigned global clinical trials in compliance with FDA and ICH GCP guidelines. You will review study data remotely, contact sites to collect documentation, resolve issues and follow-up on regulatory requirements.

The role offers a 2-year fixed-term contract, full-time 40 hours per week, and flexible working models to support work-life balance while collaborating with experienced CTMs and

Qualifications

• Remote monitoring per FDA/ICH GCP guidelines.
• Review data and resolve issues remotely.
• Coordinate regulatory documentation with sites.
• Communicate effectively with study staff.

Responsibilities

• Delivers remote site management and monitoring per protocol.
• Reviews study data remotely across multiple sources.
• Contacts sites to collect documentation and resolve queries.
• Supports regulatory reviews and training as requested.
• Collaborates with CTMs and project teams to maintain timelines.

Skills

Remote site management

Clinical monitoring

FDA/ICH GCP compliance

Data review (EDC)

Regulatory documentation

Communication with sites

Tools

EDC systems

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

2 Year Fixed Term contract

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Through our PPD® clinical research services, we support clinical trials in more than 100 countries, delivering laboratory, digital and decentralized solutions that help bring life-changing therapies to patients faster.

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

Why Join PPD, part of Thermo Fisher Scientific?

• Work on high-quality, global clinical trials across diverse therapeutic areas
• Be part of a stable, well-established organization with long-term career opportunities
• Strong collaboration with experienced CTMs and project teams
• Clear development pathways (e.g., Senior CRA, Lead CRA, CTM)
• Flexible working models that support work-life balance
• Full-time (40 hours/week)

About the role:

As an Assistant CRA, you will perform remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and company procedural documents by reviewing study data from various sources remotely. You will contact study sites to collect study documentation, resolve issues and request outstanding information.

What you’ll do:

• Develops and maintains a close and collaborative communication with the site staff. Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
• Completes/tracks/follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study‑specific guidelines. Raises manual queries in EDC when applicable.
• Remotely reviews study logs as deemed necessary.
• Conducts and documents site management calls/contacts according to the monitoring plan. Participates in investigator meetings. Investigates and follows‑up on centralized monitoring findings.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site’s ability to conduct study on a regular basis. Conducts remote investigations into site performance using a risk based monitoring approach: applying rootcauseanalysis (RCA), critical thinking and problem‑solving skills to help identify site process failure and work on corrective/preventive actions to bring the site into compliance and decrease risk.
• Providesrefresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatorydocuments), assistswithregulatory reviews, as requested, etc.
• Reviews ad‑hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.
• Provides trial status tracking and progress update reportsto study manager.
• Participatesintheinvest