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Job Details

CRA II

Company: inVentiv Health Clinical
Location: Madrid
Reference: AN-5373
Closing Date: 05 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Your main responsibilities will be: * Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely. * Review completion of proper informed consent procedures. * Ensure accurate data reporting via review of site source documents and medical records. * Interpret data to identify protocol deviations and risks to subject safety/data integrity. ...

Requirements:

Your main responsibilities will be:



* Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
* Review completion of proper informed consent procedures.
* Ensure accurate data reporting via review of site source documents and medical records.
* Interpret data to identify protocol deviations and risks to subject safety/data integrity.
* Generate queries and manage resolutions with site personnel.
* Perform investigational product accountability as per the protocol and Study Monitoring Plan.
* Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
* Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
* Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
* Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required.
* Act as primary liaison with study site personnel.
* Enter data into tracking systems as required.
* Participate in the identification and selection of investigators and clinical sites
* Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
* Provide clinical and technical support for project team as required.
* May interact with representatives of client affiliates as per project requirements.

Apply for this job: CRA II

Contact Information:

Address:  Main Office
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
SL6 7AA, UK
England
Reasons to work for inVentiv Health Clinical
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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