Clinical Research Associate

7 days ago

New York, New York, United States Medix™ Full time
{"Job Summary

We are seeking a highly skilled Clinical Research Coordinator to join our team at Medix™. The successful candidate will be responsible for preparing and processing new IRB research proposals, amendments, continuing review applications, and adverse event reports.

Key Responsibilities

  • Assist in the preparation and processing of new IRB research proposals, amendments, continuing review applications, and adverse event reports.
  • Apply qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
  • Communicate effectively and respectfully with employees and customers.
  • Know the primary resources available to accomplish the job.
  • Research simple clinical questions pertaining to the functional area.
  • File and collate trial documentation and reports.
  • Archive study documentation and correspondence.
  • Demonstrate a systematic approach to problem solving.
  • Prepare and maintain documents required to be maintained and available internally and for regulatory authorities and/or the sponsor.
  • Participate in periodic site visits from sponsor, regulatory authorities, and others to review research, source documentation, and research procedures.
  • Procure equipment and supplies needed to fulfill project requirements.
  • Record data from source documentation and/or participant interaction onto case report forms.
  • Attend to query resolution in a timely manner.
  • Ensure research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
  • Assist with study completion, study closeout, and archiving of study files.
  • Serve as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants, and representatives of professional organizations.
  • Participate in the determination of eligible candidates for study participation.
  • Engage in open and positive communication with study participants and coworkers.
  • Perform or instruct others in performing procedures for research as described in the protocol.


Schedule/Shift

Monday - Friday 8am-5pm (on-site)



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