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Clinical Trials Project Coordinator

2 months ago

New York, New York, United States Medix™ Full time

Key Responsibilities

  • Assists in the preparation and processing of new Institutional Review Board (IRB) research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional and departmental policies as well as federal regulations.
  • Study Design & Execution: Utilizes qualitative and quantitative research methodologies to carry out preparatory, regulatory, and analytical tasks throughout the study lifecycle.
  • Effective Communication: Engages in clear, respectful, and effective communication with colleagues and stakeholders.
  • Clinical Research Knowledge: Understands the primary resources necessary to fulfill job responsibilities.
  • Conducts research on straightforward clinical inquiries relevant to the functional area.
  • Organizes and maintains trial documentation and reports, ensuring proper archiving of study materials and correspondence.
  • Employs a systematic approach to problem-solving.
  • Prepares and manages essential documents required for internal use and for regulatory authorities or sponsors throughout the clinical/translational trial process.
  • Participates in regular site visits from sponsors and regulatory bodies to review research activities, source documentation, and research methodologies.
  • Procures necessary equipment and supplies to meet project demands.
  • Records data from source documentation and participant interactions onto case report forms (either paper or electronic), ensuring accuracy, completeness, and timeliness.
  • Addresses queries in a prompt manner.
  • Ensures that research information is collected and stored in compliance with regulations, policies, and good clinical practices.
  • Assists with study completion, closeout, and archiving of study files, ensuring all study data is complete and continuous, while performing ongoing checks of clinical/translational data entered on case report forms or in reports.
  • Acts as an advocate for human subjects by maintaining communication with investigators, research staff, sponsors, participants, and representatives from professional organizations and advocacy groups, ensuring the protection of human participants in research through ongoing monitoring of trial processes.
  • Contributes to the assessment of eligible candidates for study participation, ensuring that participants meet eligibility criteria. With guidance, evaluates potential participants' medical and historical information to confirm appropriate enrollment in clinical/translational trials.
  • Fosters open and positive communication with study participants and colleagues.
  • With supervision, performs or instructs others in executing research procedures as outlined in the protocol, making deviations only when necessary for participant safety and promptly reporting any deviations to the Principal Investigator or senior personnel for potential protocol amendments or safety reporting.
  • The responsibilities outlined are a general overview of the position; additional duties may be assigned as necessary.

Schedule/Shift

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