Company: inVentiv Health Clinical
Closing Date: 07 Mar 17
Salary (£): Negotiable
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance.
The Clinical Research Associate II will perform clinical monitoring activities in accordance with study guidelines, SOPs, and applicable regulations/guidance documents.
Your responsibilities will be the following:
* 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.
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