A dynamic CRO has a superb opportunity available for an experienced CRA working within large Cardiology focused projects.

This truly international organisation has won a number of new projects and for this reason is looking to expand the affiliate office based in the south of England.

Within this position you will monitor the progress of Cardiology trials at investigative sites, and ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Main Responsibilities:

• Implements and monitors clinical trials to ensure sponsor and investigator requirements are met and are compliant with applicable local regulatory requirements and ICH guidelines
• Mentors junior level CRAs and serves as a point of contact for new employees
• Working largely on Cardiology trials at least for the immediate future
• 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 updates to team members and project management
• 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
• 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
• May be assigned Lead CRA accountabilities on non-global studies

Benefits and Requirements

• Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required
• Direct monitoring experience at a CRO, Pharma or biotech company
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail preferred
• Direct experience working within Cardiology
• Knowledge of ICH and local regulatory authority regulations regarding drug research and development
• Long term career progression
• Industry renowned training
• Exceptional base salary and package

If you have the skills and experience for this opportunity please email your C.V. to Phil@stelfoxuk.com for further details and confidential correspondence

Phil is a Clinical Operations Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia

For more updates on great jobs and opportunities follow Phil on twitter - @Stelfoxclinical

Cardiology, Clinical Research Associate, Clinical Research Associate II, Clinical Research Associate III, Senior Clinical Research Associate, CRA, CRA II, CRA III, Senior CRA, Clinical Trial Monitor, Monitoring, GCP, ICH, Lead CRA, Site Management, Cardiology, England, South England
Stelfox - 13 months ago