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Safety Monitor II
Location: North Carolina
          
Clinical Research International s a full-service contract research organization with international resources dedicated to helping pharmaceutical and biotechnology companies, efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and
medical devices to the people who need them.
Safety Monitor II
Responsibilities include receipt and review of daily SAE faxes for both initial and/or follow-up reports, renaming of files, printing, logging, the sending of acknowledgments of receipt to sites and the notifications of reports to project team and sponsor.

Develops the guidelines, insures the uniform and timely reporting of adverse events by providing safety training to investigators, sites, project team members and also project specific training to the internal safety team.

Timely processing of all adverse events reports, acts as a liaison both internally and with external collaborators to ensure steps and processes are completed and prepares reports to meet regulatory reporting requirements domestically and internationally.

Responsible for the compliance of established SOP's and also the global regulatory requirements for the reporting of adverse events to all regulatory authorities.

May provide safety advice on study design strategies, analysis plans, coding and clinical  data review as well as field monitoring and drug development strategy.

Assists in the review of protocols, CRFs pages, SPM, and customization of the SAE Report forms
and their Completion Instructions for sponsor specific projects. Responsible for un-blinding, reconciliations (both interim and end of study, proofing of monthly line listings to the sponsor, assists in the preparation of Annual Reports, and updating of the Investigator’s Brochure, Product Labelling and/or Package Insert and other reports or listings as necessary.
  
Main tasks in the areas of Safety Evaluation include: Medical coding and evaluation of data entry in the Safety database, creation of case narratives in the Safety database, requests for follow-up via designated work-flow, completion of ad hoc sponsor projects, ensuring case files are logged and in chronological order and discussion of coding issues with Medical Coder.

Requirements:
Bachelor's degree in health-related field or equivalent discipline.
Minimum of 3-5 years of clinical safety experience or Master's degree and 2-4 years clinical experience.

Skills: Must possess and understand global safety regulatory requirements and pharmacovigilance, medical coding with multiple dictionaries, and proficient with multiple safety systems.

Must be able to work under time constraints to meet regulatory reporting requirements and have the ability to work on multiple simultaneous safety projects while interacting with the project teams.

 Exceptional organizational ability with attention to detail and excellent written and verbal communication skills. Ability to maintain effectiveness in a changing environment.

Knowledge of and insight into general business principles and practices as well as current business priorities and requirements.

Displays competency in required job skills and knowledge. Demonstrates success in working in a team environment.

For applications or further information please email your CV Click Here....

 

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