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senior CRA
Deze vacature staat offline! | | De opdrachtgever
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CRO in provincie Utrecht
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The Clinical Lead responsibilities include:
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations. Provides clinical and technical support for CRA I, CRA II and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs). May assume the role of a Lead CRA on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader.
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Qualifications/Skills
Education: AA, RN, BS/BA or equivalent with 3.5 years clinical trial monitoring experience. Candidate must demonstrate successful performance of CRA II level position . Previous practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company, or CRO preferred. Experience or education indicates a sound basic knowledge of medical and pharmaceutical terminology. Position requires: Excellent verbal and written communication skills, excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language. Ability to travel domestically and internationally as required and process visit reports and expense reports effectively. If applicable, ability to obtain credit cards for the purpose of paying expenses while traveling. Ability to work independently. Proficient in the use of computer and software systems. Ability to understand basic and complex medical details. Understanding of basic data processing functions preferred. Knowledge of GCP and all applicable regulatory requirements required.
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Voor meer informatie over deze functie kunt u zich wenden tot:
Dr. Arjan van den Wijngaard
FarmaSel Scientific
Consultant R&D
Hullenbergweg 353-367
1101 CP Amsterdam Z-O
tel 020 311 8770
mobiel 06 51784142
Geinteresseerden kunnen hun c.v. rechtstreeks mailen naar info@pharmamediair.nl |
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