Work Schedule* Standard (Mon-Fri)*Environmental Conditions* Office*Job Description* *Assistant CRA - Germany* *2 Year Fixed Term contract* At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Discover Impactful Work: 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. A day in the Life: * 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. 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. * outstanding/updated regulatory documents), assists with regulatory reviews, as requested, etc. * 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. 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 environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Prefer individuals who aspire to advance into a CRA role. *Knowledge, Skills, Abilities* * Basic medical/therapeutic area knowledge and understanding of medical terminology * Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and PPD procedural documents * Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) * Ability to successfully complete the RSM Onboarding Workshop * *Fluency in German and English languages (minimum C1 Level)* * Ability to evaluate medical research data * Ability to advise, counsel, and motivate investigational sites * Effective oral and written communication skills with the ability to communicate effectively with medical personnel * Excellent interpersonal and customer service skills * Good organizational and time management skills * Proven flexibility and adaptability * Strong attention to detail * Ability to work in a team or independently, as required * Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving. * Good computer skills with good knowledge of MS Office ability to learn and use appropriate software. Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt. *Benefits* We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!