Clinical Study Nurse
vor 7 Monaten
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.
**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.
- 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.
- 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 Process**:
**Who will you be working for?**
**About ClinChoice**:
ClinChoice 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 Ethos**:
Our 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
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