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In-house CRA
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90562744

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  Job posted:   Tue Jun 5, 2018
  Distance to work:   ? miles
  1 Views, 0 Applications  
In-house CRA
Job Description:
Supports clinical and quality activities for multiple projects according to departmental and project needs. Responsible for providing overall administrative and project support, including but not limited to maintaining clinical tracking systems, development and maintenance of trial master file and trial documents, preparing and distributing project supplies, and meeting coordination.
* Support clinical project team by updating and maintaining clinical systems that track site compliance and performance within project timelines.
* Act as a central contact for the Clinical Affairs team for designated administrative tasks and project communications, including maintaining the Clinical Affairs team's travel and PTO calendar.
* Develop and maintain Trial Master Files for multiple studies including
* Conducting periodic review of study files for accuracy and completeness
* Reviewing and uploading study and site regulatory documentation
* Processing study and site correspondence
* Uploading/filing IRB documentation and IRB correspondence
* Support the clinical project team in the preparation, handling, distribution, filing and archiving of clinical study documentation and reports.
* Support clinical project team with daily regulatory documentation requests and needs.
* Support the clinical project team with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information.
* Develop and maintain various study trackers including site regulatory document trackers, adverse event trackers and monitoring visit trackers.
* Assist Sponsors and sites with IRB submissions and submissions.
* Facilitate the planning and execution of project training sessions and Investigator Meetings, including but not limited to meeting logistics, planning and support.
* Provide support to Clinical QA Manager to develop and maintain all elements of the quality system, as needed.
* Run various reports from Electronic Data Capture system to support routine project management activities.
* Prepare and maintain meeting minutes from sponsor and internal weekly teleconferences.
Please send resume to
*Min Salary:* $0.00
*Max Salary:* $0.00
*State:* DC

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