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Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team to ensure that all aspects of service for assigned groups of subjects are met, through the adherence to study schedules, protocols and local clinical practice regulations and requirements. Flexible approach to working hours to accommodate the dynamic nature of research visits. Education and Experience: Registered Nurse or Medical Assistant with at least 2 years of post-registration experience. Previous experience as a Research Nurse or Medical Assistant including a recent (within the last 1 year) ICH-GCP update. Experience in neurology is desirable. Skills Requirements: Infusion experience essential. Good phlebotomy skills. ECG recording. Managing infusion reactions. Demonstrated organisational skills. Proven flexibility and the ability to work under pressure. Good communication skills. Proficiency in German mandatory, English desirable. Proactive contribution towards the team by being a flexible team player. Ability to work effectively both in a team & independently in a fast-paced environment. Excellent understanding of the clinical processes. Good knowledge of clinical trials, including EU Clinical Trials Directives, Good Clinical Practice for Clinical Trials, and German regulations is desirable, training can be provided. Excellent computer skills required, MS Office proficiency at a minimum. The Application ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated #LI-DNP

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.As a Project Manager Study Start-Up at Fortrea , you will be central to the successful execution of clinical trials for new drugs in Germany. Location: MunichThis position will allow you to participate in the development of innovative medicines that set a new standard , especially in the field of oncology , while working exclusively for one of our most important international clients . If you are looking for an opportunity to take on more responsibility, demonstrate your leadership skills and be able to use your expertise in the field of study start-ups, then this position is a great opportunity. We are looking for an individual with good and solid study start-up knowledge combine with an interest in financial matters such as budget and contract negotiations, local regulatory environment and submission and approval processes . What you can expect from us : a meaningful job in a stable , diverse, successful and reputable company an attractive and competitive salary , including 13th salary and holiday pay a true work-life balance Flexible working hours and company regulations to compensate for time off Travel time = working time Comprehensive onboarding with the support of your personal mentor a permanent home office employment contract an attractive , employer-funded pension plan Excellent training and development opportunities as well as support for your personal training plans Continuous support from your line manager Your tasks : Organization and management of all necessary submissions and applications to ethics committees and authorities in Germany Budget responsibility including contract negotiations and conclusion with the study centers Management and coordination of local start-up processes including vendor management Country- specific adaptation of global study documents Close collaboration with internal and external teams Support in training , mentoring and further development of new employees Participation in customer-specific working groups and other internal projects as a Subject Matter Expert Your background : University degree in natural sciences such as biology , biochemistry , chemistry , public health , pharmacology , medicine , etc.; alternatively , a completed vocational training in the field of health / nursing or equivalent professional experience (e.g. as a study nurse , research nurse , study coordinator , etc.) Sound professional experience in the field of Study Start Up Experience with submissions to the German ethics committees and authorities Proven leadership skills through coaching , mentoring and/ or coordination of teams Efficient time management and organizational talent as well as a careful , detailed way of working Skills to establish and maintain effective and trusting working relationships with internal and external partners Excellent communication skills in business- fluent German as well as good written and spoken English skills are a must We look forward to your application ! Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.