This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest general platform for the LGBTQ+ business community. Environmental Conditions Office Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Ensures a shared responsibility with other project team members on issues/findings resolution. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.



Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Conducts on-site file reviews as per project specifications. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to other project work and initiatives for process improvement, as required. Bachelor's degree in a life science related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Total experience: at least 3 years as a CRA Cell therapy experience: at least 2 years of on-site, hands-on experience Effective clinical monitoring skills Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manages Risk Based Monitoring concepts and processes Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills

📌 Clinical Trial Assistant (España)
🏢 Thermo Fisher Scientific
📍 España