Clinical Research Associate

3 weeks ago

Franklin Lakes, United States MILLENNIUMSOFT Full time
Position                          : Clinical Research Associate
Location                         : Franklin Lakes, NJ
Duration                         : 12 +months contract
Start Time                       : 08:00 AM
End Time                         : 05.00 PM
Total Hours/week            : 40.00
                                                         
 
Qualifications:
  • The Clinical Research Associate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials.
  • The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management.
  • The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data.  
  • The CRA is responsible for preparing reports of study results for investigators and internal development teams, assisting in preparation of regulatory submissions, and supporting publication activities.
  • The CRA will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities.
 
Responsibilities:
  1. Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development.  Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products.
  2. Provide product development teams and other functions with technical and clinical expertise and support.
  3. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures.
  4. Specific Responsibilities:
  5. Develop the study design and protocol(s)
  6. Screen, select, and qualify principal investigators and investigational sites
  7. Conduct negotiations of clinical site agreements and contracts
  8. Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials
  9. Develop time schedules and budgets necessary to manage the clinical evaluations
  10. Coordinate and plan availability of supplies and shipment of materials
  11. Train clinical evaluation participants in study products and procedures. 
  12. Monitor sites to assure that the Protocol is understood and followed
  13. Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics
  14. Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators
  15. Support the reporting of performance data to regulatory authorities
  16. Assumes responsibility for occasional special departmental projects
  17. Anticipate 10% to 25% travel (primarily domestic; international travel a possibility

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