Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Study Start Up Specialist / inhouse CRA (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Bayern
Branche: Forschung und Entwicklung im Bereich Natur-, Ingenieur-, Agrarwissenschaften und Medizin
Ihre Aufgaben:
- Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations
- Maintenance of allocated site's information in the Trial TrackerTM Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
- Working with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
- Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review)
- Where applicable, provide logistical support for clinical trial supply coordination
- Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations
- Maintenance of allocated site's information in the Trial TrackerTM Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
- Working with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
- Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review)
- Where applicable, provide logistical support for clinical trial supply coordination
Ihre Qualifikation
- Good organizational and time management skills
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred
- Good communication skills, oral and written
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in a team environment
- Detail and process oriented
- Positive attitude and approach
- Interact with internal and external customers with high degree of professionalism and discretion
- Multi-tasking capability
- Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.).
- Flexible and adaptable to a developing work environment
Skills:
- CRA