CRA (all levels) / Global CRO / Full Service / Growth Potential / iro up to €75k per year (plus car allowance)
RBW Consulting are excited to announce an opportunity on behalf of one of our close clients. This company are a renowned CRO with leading healthcare intelligence and a European culture. They treat unmet disease target areas and advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. The Senior CRA will join a high performing team in Germany reporting into a dedicated German line manager who is fully focused on you and your team.
Here, you will have access to Ph1 trials, niche/rare treatments, blockbuster drugs and/or biosimilars. Furthermore, the chance to work with a wide range of protocols and therapeutic areas. Not only will you gain exposure to international study settings but you will gain access to thousands of practical and diverse trainings modules in-house that can be instructor-led or self-learning (where feasible). Structured development programs have a proven track record for development of their employees; leading to strong employee engagement and retention. Additionally, career pathways are in place to allow for vertical and lateral movement towards CTM, CPM, Programming, Regulatory, and Study Start Up positions; the possibilities to explore the areas of research you enjoy are endless with this company.
Regarding the logistics of the CRA position at this company, studies are assigned with a human element attached. Your line manager will try their best to assign you to studies where you have experience, interest, and can bring true value. They operate on a credit-based system as opposed to a metrics-based one, meaning any overtime you perform can be reimbursed in the form of time off. Typically, you will be assigned 2-3 sponsors depending on the complexity of the study and will have open dialogue with your line manager to ensure your responsibilities are manageable.
- Autonomy of investigator sites with full responsibility for the successful management of sites through study life cycle (start-up to close-out);
- Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas;
- Prepare accordingly and attend investigator meetings, coordinating timely delivery and subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues;
- Perform source document verification and case report form review;
- Perform regulatory document review;
- Conduct study drug inventory;
- Perform adverse event and serious adverse event reporting and follow-up; and
- Assess patient recruitment and retention.
- Bachelor of Science in health-related field (a BSN is preferred)
- Proven Snr CRA experience; 1 year minimum
- Broad knowledge of medical terminology and clinical patient management
- Basic knowledge of drug therapy techniques and clinical research methodologies
- Fully remote working flexibility
- Credit-based system (no metrics and overtime reimbursed in the form of time off)
- Dedicated Line Manager (DLM)
- Mentor/Guide alongside DLM
- Comprehensive pension plan and life insurance
- Access to Ph1 studies, blockbuster drugs and/or biosimilars
- International study setting exposure
- Tailored development programs and career pathways
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1293 364114
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