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  Clinical Research Associates - Nationwide  
  Clinical Research Manager - San Diego and South San Francisco  
  Safety Monitor II - North Carolina  
  Clinical Research Physician-Hampshire, UK - South East  
  Clinical Project Managers (All levels) Belgium, Germany, UK - South East, UK - East Anglia, UK - Scotland (Central)  
       
    Clinical Research Associates - Nationwide
    
Clinical Research International is 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 and biologics to the people who need them.

Duties and responsibilities:
Assists with coordinating and performing all aspects of the clinical monitoring process in accordance with GCPs and SOPs.
Conducts site visits to verify that: the rights and well-being of human
subjects are protected; the reported trial data are complete, accurate, and verifiable per source documents; and that the trial is conducted in compliance with the currently approved protocol, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs).
Other responsibilities include verifying proper storage conditions, accountability, and disposition of the investigational products and maintenance of up-to-date and accurate investigator study files. Submits written reports of investigational site findings. May be involved in organizing or participating in investigator's meetings, study report writing, and the development of protocols, case report forms and study procedures manuals.
Work with multidisciplinary project teams in preparing and implementing clinical development plans and provides clinical research expertise in support of other departments.
Assist with identifying and evaluating qualified investigators, investigational sites, and CROs to perform studies and provide clinical consultations via site visits, site profiles, historical performance and interactions with internal and external customers.
Assist with monitoring and/or supervising the monitoring activities performed by contract research organizations (CRO); serve as a trainer and  resource for contract research organizations (CROs).
Assist with establishing policies and ensuring adherence to applicable regulatory and clinical standards by participating in the creation, review, and approval of departmental operating procedures.
Develop and maintain expertise in regulations for all geographies and types of studies. Serve as a resource related to clinical trial regulations.
Develop knowledge related to projects and therapeutic areas to better interact with investigators and external study coordinators.
  Qualifications:
Bachelor's degree in biology, medical technology (registered nurses also required).
Minimum 6 months of related work experience.
Knowledge of GCP, ICH and FDA Regulations.
Excellent oral and written communication skills.
High degree of professionalism.
Ability to work both independently and in a team environment.
Proficient report writing (e.g., monitoring reports, letters to sites).  

 
   

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

 

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Clinical Research Associate Training Program