Join to apply for the Senior Clinical Trial Associate role at Catalyst Clinical ResearchJoin to apply for the Senior Clinical Trial Associate role at Catalyst Clinical ResearchGet AI-powered advice on this job and more exclusive features.Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.Com.As a Senior Clinical Trial Associate you are responsible for providing the administrative support to the clinical development / project teams and maintaining a range of clinical documentation. You will be focused on supporting external client teams as well as our internal Clinical Services team. You will work closely with project teams to ensure that Clinical Trial Administration is performed in line with ICH-GCP allowing successful delivery of trials whilst protecting subjects’ rights, safety and wellbeing and the production of reliable clinical trial data.Position Accountabilities / ResponsibilitiesSupport the clinical trial activities with regard to time, cost and quality and in accordance with SOPs, ICH-GCP guidelines and relevant regulationsSet up and maintain the documentation folders associated with product development and the Trial Master File (TMF) in compliance with ICH-GCPEnsure the TMF index is kept up to dateCoordinate the collection of essential documents during site set-upAssist in the development of processes and procedures in order to ensure that robust forecasting and scheduling of trials occursAssist the project managers in the production of study reports and updates as requiredSet up trial specific meetings, taking minutes and tracking screening and enrolment across clinical sitesTrack and process investigator site paymentsManage the clinical trial supplies for a study, including the tracking and shipment of materials e.G. lab kitsAssists the project team with preparation and shipment of Clinical Trial documentation including :
Investigator Site File, Pharmacy File, Investigator Brochure, Protocol and study manuals.Update and maintain trial tracking systems in accordance to the demands of the study e.G. investigational product tracking, payment tracking, monitoring visit tracking etc.Serve as an office-based point of contact for all sites during the trialDevelop and maintain good working relationships with Investigators and study staffAssist with corporate administration activities according to need and availabilityPosition Qualifications And RequirementsEducation :
Degree or equivalent qualification in life sciences or nursingExperience2+ years’ experience in clinical trial processes and procedures including regulatory standardsRequired Certifications :
N / ARequired SkillsA good understanding of ICH-GCP and regulatory requirementsProven track record in working within clinical research in the pharmaceutical, CRO or NHS environmentExperience in maintaining Trial Master Files / Investigator Site Files in compliance with ICH-GCP (ideally experience in using the DIA reference model).Ability to work collaboratively with others, influencing and managing conflictWillingness and ability to travel domestically (and occasionally internationally) as requiredExcellent verbal and written communication and interpersonal skillsStrong organisational and time management skills with an ability to multi task and work independentlyStrong technical skills using PowerPoint, Excel and WordWorking Conditions :
Sedentary work that primarily involves sitting / standing. Employee may be office or home based. Seniority levelSeniority level Mid-Senior levelEmployment typeEmployment type Full-timeJob functionJob function Research, Analyst, and Information TechnologyIndustries Research ServicesReferrals increase your chances of interviewing at Catalyst Clinical Research by 2xGet notified about new Clinical Trial Associate jobs in Spain .Madrid, Community of Madrid, Spain 4 days agoMadrid, Community of Madrid, Spain 3 weeks agoClinical Research Associate II / Sr. CRA, Spain Clinical Trial Manager II (CTM II), Dermatology & Rheumatology, SpainMadrid, Community of Madrid, Spain 1 month agoClinical Research Associate II - FSP Team - Home Based MalagaMadrid, Community of Madrid, Spain 2 weeks agoMadrid, Community of Madrid, Spain 1 month agoClinical Trial Manager II or Senior. FSP Model. Barcelona or Madrid. One year Project. Clinical Trial Manager II or Senior. FSP Model. Barcelona or Madrid. Sponsor Dedicated CRA II - Home Based PolandMadrid, Community of Madrid, Spain 1 week agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.J-18808-Ljbffr
#J-18808-Ljbffr