Date: 09-Oct-2012
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Senior CRA in Biotech
* Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and GCP guidelines o Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies
* Provides regular clinical status information to team members and project management
* Performs billable work in accordance with company policies, procedures, and Standard Operating Procedures
* Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff
* Communicates common site trends to Lead CRA, Project Manager or other project team members
* Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, GCP guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
* Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites
* Ensures Serious Adverse Event (SAE) reporting according to project specifications
* Responds to requests from investigative sites in a timely fashion
* Mentors junior level CRAs and serves as a resource for new employees
* Support EC submissions and follow this process to approval
* Support the CA / Health Authority submissions if required, and follow this process to approval
* Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required
* An advanced degree (e.g., M.S., M.B.A., PharmD, etc) preferred
* Read, write and speak fluent English; fluent in host country language
* Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail preferred
* Knowledge of ICH and local regulatory authority regulations regarding drug research and development preferred for CRA 1; required for CRA 2 and 3
* Clinical research employment experience required for CRA 2 and 3; preferred for CRA 1
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
