Clinical Research Coordinator

UNC-Chapel HillChapel Hill, NC
Onsite

About The Position

This position serves as the Clinical Research Coordinator for the ADAPT clinical trial, an NIH-funded, randomized, triple-masked, placebo-controlled study investigating marine lipid precursors of specialized pro-resolving mediators in adults with chronic temporomandibular disorder (TMD)-related pain. The Study Coordinator is responsible for the day-to-day coordination and execution of study activities in accordance with the approved protocol, institutional policies, and applicable Federal regulations governing human subjects research. Primary responsibilities include coordinating participant recruitment, screening, enrollment, scheduling, and retention; supporting standardized clinical assessment procedures following training and calibration; and assisting with biospecimen collection and coordination of specimen handling and documentation in accordance with study protocols. Occasional work outside of standard business hours (including early mornings or evenings) may be required to accommodate participant scheduling and study visits. The position is responsible for accurate study data collection, entry, and maintenance, as well as maintenance of regulatory and study documentation, including Institutional Review Board (IRB) submissions such as initial applications, amendments, continuing reviews, and reportable events. The Study Coordinator ensures study activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and human subjects protection requirements. The role supports communication and coordination among investigators, clinical staff, laboratory personnel, and study participants to facilitate efficient study implementation. The position also supports study logistics, participant visit coordination, tracking systems, and administrative documentation necessary for study operations.

Requirements

  • Experience as a Clinical Research Coordinator.
  • Familiarity with NIH-funded studies.
  • Knowledge of Good Clinical Practice (GCP) guidelines.
  • Understanding of human subjects protection requirements.
  • Ability to coordinate participant recruitment, screening, enrollment, scheduling, and retention.
  • Ability to support standardized clinical assessment procedures.
  • Ability to assist with biospecimen collection and coordination.
  • Proficiency in study data collection, entry, and maintenance.
  • Experience with regulatory and study documentation, including IRB submissions.
  • Strong communication and coordination skills.
  • Ability to manage study logistics and tracking systems.

Nice To Haves

  • Experience with randomized, triple-masked, placebo-controlled studies.
  • Experience with studies investigating marine lipid precursors.
  • Experience with chronic temporomandibular disorder (TMD)-related pain studies.

Responsibilities

  • Coordinating participant recruitment, screening, enrollment, scheduling, and retention.
  • Supporting standardized clinical assessment procedures following training and calibration.
  • Assisting with biospecimen collection and coordination of specimen handling and documentation in accordance with study protocols.
  • Accurate study data collection, entry, and maintenance.
  • Maintenance of regulatory and study documentation, including Institutional Review Board (IRB) submissions such as initial applications, amendments, continuing reviews, and reportable events.
  • Ensuring study activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and human subjects protection requirements.
  • Supporting communication and coordination among investigators, clinical staff, laboratory personnel, and study participants to facilitate efficient study implementation.
  • Supporting study logistics, participant visit coordination, tracking systems, and administrative documentation necessary for study operations.
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