Assistant CRA - FSP (m/f/d)

Thermo Fisher ScientificRemote, GermanyremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

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 root cause analysis (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. Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory 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 reports to study manager. Participates in the investigator payment process, if applicable. Liaises with internal staff to promptly collect documents, review data points and findings from EDC and file reviews, etc. Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses. Detailed task assignment and responsibilities are outlined on the task matrix, as well as any applicable protocol guidelines. Keys to Success: Education Bachelor’s Degree in a life science-related field. Experience Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical

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