Are you a Junior CRA or a CRA with up to 2 years' experience working for a CRO and looking for a chance to start with one of the greatest sponsors worldwide?
Our client, awarded with the "Best Employer 2015" award by Great Places To Work is seeking for new talents for their CRA team to build a long lasting work relationship with you!
If you can answer these questions with yes, then give us a call!
Are you looking for true team spirit in your work?
Do you understand yourself as a relationship manager with the study site rather than a mere data collector?
Do you think you have what it needs to be a great CRA?
Do you look for commitment in your job?
Curiosity and flexibility as well as enthusiasm are the things that drive you?
You live in the Rhein-Main area, Berlin, in the north or in the east of Germany?
Act as single point of contact with assigned sites for specific trials (Site Manager)
Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
Onsite, risk-based and remote monitoring
Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
Ensures site-staff are trained, and complete the data entry and resolve queries within expected timelines
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
Ensures site study supplies (such as Non-IP, lab kits, drugs) are adequate for trial conduct and appropriately used, handled, stored, returned, and documented
Ensures accuracy, validity and completeness of data collected at trial sites
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints)
Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team
Attends regularly scheduled team meetings and trainings
Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. OSQMV
University degree in life science, nursing, or other relevant experience in life science
Solid understanding in of the drug development process including ICH/GCP and local regulatory requirements
Very communicative and open person
Solid computer skills
Proficiency in speaking and writing English and German
Willingness to travel with occasional/regular overnight stay away from home depending on the region
Flexible mind-set and ability to work at a fast pace in exploratory study teams