CRA / Clinical Research Associate - Spain - Home-Based

3 x CRA / Clinical Research Associate - Spain

18-24 month Fixed Term Contract, Home-based, 3 positions available.

Scope:

Supports team on clinical trials activities, particularly in the planning and start-up phases

Description of main activities:

- Assists the Group's MDs and Clinical Research Scientists in the preparation of the study protocol, amendments, informed consent form

- Supports the team in the preparation of other study documents in due time (CRF, diary cards, study manuals, IND updates, clinical summaries, etc) and mantains accurate and up-to-date information in project management systems and project specific tracking systems.

- Ensures delivery of study materials together with regional staff and Group Project Management and ensures proper handling of study materials during shipment to investigational sites.

- Ensures that appropriate documents are available for regional teams for study MoH submission according to local requirements

- Attends investigators meetings and provides GCP/ICH/FDA/SOP and study specific training as appropriate

- Assists in the preparation of the NDA/BLA and other regulatory documents; assists in the identification and selection of CROs if required.

- Checks that study expenses/payments are done in accordance with the planned study budget and in adherence to the Financial Agreement.

Professional/Technical requirements:

- Degree in a science or health related discipline.

- Minimum of 1/2 years of experience as Clinical Research Associate.

- Knowledge of GCPs and ICH Guidelines.

- Experience preparing MoH submission packages (i.e. filing NDA and PLAs) is a plus.

- Good communication skills (both verbal and written).

- English proficiency.

- Work independently within a matrix organization.

- Problem solving.

- Strategic thinking.

- Proactive nature.

Keywords: CRA "clinical research associate" "clinical monitor" "clinical research monitor" "clinical research" "clinical" "clinical trials" "ich gcp" "ich-gcp" "pharmaceuticals" "biotech" "cro" "clinical research organisation" "pharmaceutical" "spain" "spain clinical" "clinical project associate" "monitoring" "immunology" "IID" "Infectious disease" "respiratory"

This position, CRA / Clinical Research Associate - Spain - Home-Based, was posted on August 17, 2010. Since this job has been published, it has been viewed 46 times.