Study Nurse

About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.The Study Nurse coordinates and manages clinical studies with drugs, medical devices and cosmetics as Study Nurse under the supervision of the Principal Investigator (PI) in cooperation with the TFS In-house Clinic study team according to the policies and Standard Operating Procedures of TFS and in compliance with Good Clinical Practice as well as with the national and international regulations for clinical studies and data protection.As part of our Functional Solutions team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.Key ResponsibilitiesStudy Set-up:Complete feasibility questionnaires from SponsorsPrepare and attend Pre-study visitsComplete the site qualification questionnaire for EC submissionParticipate in the investigator meetings of the SponsorsPlan and attend Site Initiation VisitsSupport patient recruitment in collaboration with the investigatorsStudy Conduct according to the protocol-related tasks delegated by the PI:Coordinate, prepare and conduct patients visits according to the study protocol and support the investigators also in screening activitiesConduct diagnostic tests such as vital signs, etc.Collect and process biological samplesManage laboratory shipping logistics in accordance with ICAO/IATA Dangerous Goods RegulationDispense and administer the Investigational Medicinal Product to study participants following the instructions of the investigatorsManage the Drug Accountability including storage, preparation of the Investigational Medicinal ProductMain contact person for communication with study participants, CRAs and SponsorsManage patients reimbursements and investigator feesStudy project documentation:Prepare and maintain patient files for source documentationCapture Source Data in various electronic or paper-based Data Capture SystemsResolve Data Queries in collaboration with the investigatorsMaintain the Investigator Site FilesAssist in Serious Adverse Event reportingPrepare, support and post-process monitoring visits and audits/inspectionsArchive study documentsQualificationsWork Experience as Study Nurse (2 years ideally) or completed vocational training as Nurse, Medical Documentation Assistant, Medizinische Fachkraft (MFA) or similar health professionExcellent organizational skills, ability to prioritise and handle multiple competing priorities and timelinesExcellent verbal and written communication skillsAbility to work independently and in a teamKnowledge of the Good Clinical Practice regulations and IATA requirementsVery good command of written and spoken EnglishGood knowledge of MS OfficeWillingness to travel on occasionWhat We OfferWe provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.A Bit More About UsOur journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.Securing the Path from Science to Life