In-House CRA II

Description:
Our client is currently in need of in-house CRA's for Phase I/II/III studies to support assigned projects by implementing clinical pharmacology studies from study synopsis to final study report according to specifications and time-lines of the Clinical Development Plan and regulatory requirements.
To plan all logistical aspects, authorship or co-authorship of clinical study protocol, interaction with internal partners and external clinical sites, on-site study monitoring, source data verification, maintenance of study files, authorship or co-authorship of summary report or final study report.

In addition, the CRA II may be asked:
• To serves as a CP Study Team Leader
• To generate (or contribute to ) study/project-related documents (protocol, regulatory documents, reports, summaries, updates for project teams and management, minutes)
• To provide CRA support to other departments and line functions e.g. GCP-QA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) and to cross-functional working groups as required
• To identify and evaluate new centers suitable for performing CP studies in healthy volunteer and patients, including suitability for complete outsourcing (in collaboration with CORM)
• To train/coach/mentor CRAs with less advanced knowledge and experience
REQUIREMENTS
Education:
BSc or MSc in life sciences or nursing; PhD level scientist with biological/pharmacological background; PharmD.

Experience:
• At least two years of clinical pharmacology, clinical research or research nurse experience (CRO, academic institution, hospital or industry).
• Potential or demonstrated ability to cope with both scientific aspects and operational tasks in a multidisciplinary matrix organization (teamwork).
• Some knowledge of drug development process is highly desirable.
• Fluent in written and spoken English, knowledge of a second language an advantage.
• Knowledge of computer technology
• Verbal and written fluency in English
• Excellent organizational skills

If you would like to apply for this position, please forward a word version of your resume to [Click here for email] for immediate consideration.