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In-House (CRA)

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HCRI is looking for an in-house Clinical Research Associate to join its rapidly growing Site Management group and work under the direction of the Clinical Site Manager.  The In-House Clinical Research Associate may assist with any of the functions of the Clinical Site Manager as directed by the CSM, including assuring that the project team that he/she leads meets all deadlines and is also required to maintain a close effectual working relationship with Sponsors, Research Coordinators and Principal Investigators and regional CRAs assigned to studies.Primary Duties:·         Coordinate/manage activities as related to the conduct of all phases of pharmaceutical, biotechnology and medical device clinical trials. ·         Maintenance of departmental standard operational procedures and guidelines.·         Works closely with investigative sites during the Regulatory process from start-up through close-out phases.·         The CRA will be responsible for the implementation and conduct of clinical studies including study planning, execution, monitoring and completion activities.·         Works closely with other HCRI departments to ensure the overall study timelines are met.·         Develop and maintain databases for tracking of regulatory documents, work flow process and other essential trial related documents. ·         Design and review Confidentiality Agreements, Informed Consent forms and Clinical Trail Agreements and other study specific forms.   ·         Organize and preparation of trial related material and presentations for Investigator meetings.  Will present as necessary at Investigator and Coordinator Meetings.·         Participate in the training of investigative sites on protocol and procedures.·         Work with Clinical Site Manager and Sponsor in identifying and screening qualifications of appropriate investigative sites.·         Help to maintain a site/investigator selection system/process.·         Participation and review of proposals and budgets·         Provide centralized site support, communication and coordination to assure accurate and timely completion of all contracted activities.·         Provide ongoing site management support through project completion.·         Clinical trials research experience through exposure to protocols in a variety of therapeutic areas.·         Knowledge of internal SOP’s, FDA/ICH guidelines to GCP’s and regulatory compliance.·         Able to work independently and in a team environment.·         Facilitate general communication among the research centers, HCRI project teams, sponsors, site monitors and vendors relative to the responsibilities itemized above.·         Must have conducted all types of study visits from qualifying site assessments to closeout.  Secondary Duties: 
  • May be called upon to perform Clinical Site Management Coordinator tasks
  • Produce spreadsheets on special projects for the Project Managers
  • Organize and distribute internal and external project reports
  • Coordinate internal and external meetings
  • Direct calls to the appropriate resources
  • Review mail/distribute/fax correspondence
  • Edit and/or review newsletters
 Education:       Required:          B.S/B.A degree or Bachelors in a Health Related Field  Preferred:         Yrs. of related experience: Required:  1-3 years experience in clinical study management and site monitoring.   

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Submission Date May 16, 2008
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