About The Position

Coordinates and assists with the implementation of multiple clinical research studies. Manages the handling of adverse events, compliance and other participant-related issues. Handles resolution of data queries with sponsor. Responsible for completing, organizing, and submitting Institutional Review Board (IRB) for phase 1 - 4 trials required by the sponsor. Conducts initiation, monitoring and close out visits with the sponsor. Coordinates the preparation and delivery of departmental communications, presentations and marketing/educational materials. Collaborates to ensure the compliance with local, state and federal regulations and standards. Assists with responding to and preparing for audits and participates in audits. Processes and ships research specimens per protocol guidelines.

Requirements

  • High School Diploma or Equivalent (Required)
  • No previous work experience required.
  • ACCOUNTABILITY
  • ACCURACY
  • CLINICAL RESEARCH - REGULATORY COMPLIANCE
  • CUSTOMER SERVICE
  • DEVELOPS RELATIONSHIPS
  • EFFECTIVE COMMUNICATION
  • PATIENT AND FAMILY CENTERED CARE
  • RESEARCH - REPORTING - COORD
  • RESPONDING TO CHANGE
  • STANDARDS OF BEHAVIOR
  • Requires critical thinking skills, effective communication skills, decisive judgment and the ability to work with minimal supervision.
  • Demonstrates ability to work effectively as a team member.
  • Ability to multi-task.

Responsibilities

  • Manages the handling of adverse events, compliance and other participant-related issues.
  • Handles resolution of data queries with sponsor.
  • Responsible for completing, organizing, and submitting Institutional Review Board (IRB) for phase 1 - 4 trials required by the sponsor.
  • Conducts initiation, monitoring and close out visits with the sponsor.
  • Coordinates the preparation and delivery of departmental communications, presentations and marketing/educational materials.
  • Collaborates to ensure the compliance with local, state and federal regulations and standards.
  • Assists with responding to and preparing for audits and participates in audits.
  • Processes and ships research specimens per protocol guidelines.
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