Soc/Clin Research Specialist-CEDAS

UNC-Chapel Hill•Chapel Hill, NC

1d•Onsite

About The Position

The Center for Gastrointestinal Biology and Disease (CGIBD) is seeking an experienced, part-time Clinical Research Coordinator (CRC) to support ongoing gastrointestinal (GI) clinical trials. The CRC will support multiple investigator-initiated and sponsor-led clinical trials and will work closely with Principal Investigators, study teams, sponsors, and regulatory bodies to ensure high-quality, compliant study conduct.

Requirements

Experienced Clinical Research Coordinator (CRC)
Experience supporting ongoing gastrointestinal (GI) clinical trials
Experience supporting multiple investigator-initiated and sponsor-led clinical trials
Ability to work closely with Principal Investigators, study teams, sponsors, and regulatory bodies
Proficiency in collecting study data per protocol using surveys, clinical observations, electronic medical record abstraction, and biospecimen collection
Ability to perform clinical tests and study procedures in accordance with study protocols and required training
Skill in accurately recording study data and completing electronic or paper case report forms in compliance with Good Clinical Practice (ICH GCP) and ALCOA C principles
Ability to maintain high standards of data quality and documentation integrity
Experience creating, maintaining, and organizing essential study documentation (e.g., delegation of authority logs, training records)
Experience developing, submitting, and maintaining regulatory applications and study materials, including informed consent forms and recruitment materials
Ability to identify, gather, and retain required regulatory documentation in accordance with sponsor, IRB, and institutional requirements
Experience preparing for, coordinating, and participating in monitoring visits; resolving queries and supporting implementation of corrective actions
Ability to track, document, and report protocol deviations and adverse events; participate in root cause analyses (RCAs) and corrective and preventive action (CAPA) development
Experience maintaining study supplies and coordinating biospecimen processing, tracking, and shipment
Ability to screen and recruit research participants per protocol and institutional SOPs
Skill in coordinating and supporting participant visits and follow-up activities
Ability to track study enrollment and participant accrual metrics
Experience contributing to study start-up activities, including document development, system setup, and coordination with sponsors and internal teams
Experience participating in site initiation visits, study start-up meetings, and close-out visits
Ability to assess study needs and implement strategies to optimize visit flow, recruitment, and participant retention
Skill in assisting with the development of study source documents, checklists, data collection tools, and internal workflows
Ability to independently communicate with sponsors, regulatory authorities, and UNC offices regarding study-related matters, escalating issues as appropriate

Responsibilities

Collect study data per protocol using a variety of methods, including surveys, clinical observations, electronic medical record abstraction, and biospecimen collection.
Perform clinical tests and study procedures in accordance with study protocols and required training.
Accurately record study data and complete electronic or paper case report forms in compliance with Good Clinical Practice (ICH GCP) and ALCOA C principles.
Maintain high standards of data quality and documentation integrity throughout the study lifecycle.
Create, maintain, and organize essential study documentation (e.g., delegation of authority logs, training records).
Develop, submit, and maintain regulatory applications and study materials, including informed consent forms and recruitment materials.
Identify, gather, and retain required regulatory documentation in accordance with sponsor, IRB, and institutional requirements.
Prepare for, coordinate, and participate in monitoring visits; resolve queries and support implementation of corrective actions as needed.
Track, document, and report protocol deviations and adverse events; participate in root cause analyses (RCAs) and corrective and preventive action (CAPA) development.
Maintain study supplies and coordinate biospecimen processing, tracking, and shipment when applicable.
Screen and recruit research participants per protocol and institutional SOPs.
Coordinate and support participant visits and follow-up activities.
Track study enrollment and participant accrual metrics.
Contribute to study start-up activities, including document development, system setup, and coordination with sponsors and internal teams.
Participate in site initiation visits, study start-up meetings, and close-out visits.
Assess study needs and implement strategies to optimize visit flow, recruitment, and participant retention.
Assist with the development of study source documents, checklists, data collection tools, and internal workflows.
Independently communicate with sponsors, regulatory authorities, and UNC offices regarding study-related matters, escalating issues as appropriate.