UTS - Temporary Clinical Research Coordinator at UNC Chapel Hill

UNC-Chapel Hill•Chapel Hill, NC

5d•Hybrid

About The Position

This position supports day-to-day research operations across multiple ongoing clinical research studies within the Better Tomorrow Network. The Clinical Research Coordinator will be responsible for executing study protocols, maintaining data quality, managing participant visits, and ensuring regulatory compliance. The role involves close collaboration with participants, research teams, sponsors, and regulatory entities.

Requirements

Experience with clinical research protocols.
Familiarity with Good Clinical Practice (GCP) and ALCOA-C principles.
Experience with data collection and case report forms (electronic or paper).
Ability to manage study visits and participant follow-up.
Experience with participant recruitment and retention.
Knowledge of regulatory documentation and submission processes.
Experience preparing for and participating in study monitoring visits.
Ability to track, document, and report protocol deviations and adverse events.
Understanding of institutional policies, federal regulations, sponsor requirements, and study protocols.
Experience screening and recruiting study participants.
Proficiency in communication with research participants and external partners.
Experience with study start-up activities and project planning.
Ability to develop and implement standard operating procedures.
Experience participating in site initiation, investigator, and closeout visits.
Skills in assessing project needs and optimizing study workflows.
Experience creating source documentation, checklists, and trackers.
Ability to develop and maintain data management and operational tracking tools/systems.
Experience coordinating and communicating with external clinical sites, community partners, sponsors, and regulatory entities.
Ability to maintain study supplies, laboratory kits, and administrative materials.
Experience tracking, processing, and shipping biospecimens.

Nice To Haves

Trauma-informed and survivor-centered approaches in participant support.
Experience with root cause analyses (RCAs) and corrective and preventive action plans (CAPAs).

Responsibilities

Collect study data through a variety of methods per study protocol (e.g., surveys, interviews, electronic medical record abstraction, observational assessments, biospecimen collection, and study procedures).
Maintain high standards of data quality and accuracy.
Perform clinical tests and procedures in accordance with study protocols following appropriate training.
Record study data and complete applicable case report forms (electronic or paper) in accordance with Good Clinical Practice (GCP) and ALCOA-C principles.
Manage study visits and participant follow-up activities, including scheduling, coordination, preparation of study materials, and participant communication.
Support participant recruitment and retention efforts using trauma-informed and survivor-centered approaches.
Create and maintain administrative study documentation, including delegation of authority logs, training records, and regulatory binders/files.
Develop and submit regulatory applications and study materials, including informed consent forms and recruitment materials.
Identify, gather, organize, and maintain required regulatory documentation.
Prepare for study monitoring visits, coordinate monitoring activities, resolve data queries, and assist with implementation of corrective actions as applicable.
Track, document, and report protocol deviations and adverse events.
Participate in root cause analyses (RCAs) and development of corrective and preventive action plans (CAPAs).
Ensure study activities are conducted in compliance with institutional policies, federal regulations, sponsor requirements, and study protocols.
Screen and recruit study participants according to study protocols and applicable standard operating procedures.
Track participant accrual and retention metrics across studies.
Communicate professionally and compassionately with research participants and external partners while supporting trauma-informed research practices.
Contribute to study start-up activities and project planning, including development of study materials and coordination of research activities.
Assist with development and implementation of standard operating procedures to support quality assurance and standardized best practices.
Participate in site initiation visits, study start-up meetings, investigator meetings, and closeout visits.
Assess project needs and employ strategies to optimize study workflows, recruitment, retention, and operational efficiency.
Create source documentation, checklists, trackers, and other tools to support compliant and efficient data collection.
Develop and maintain data management and operational tracking tools/systems.
Coordinate and communicate with external clinical sites, community partners, sponsors, regulatory entities, and UNC administrative offices regarding project-related matters, escalating issues appropriately.
Maintain study supplies, laboratory kits, and administrative materials as needed.
Track, process, and ship biospecimens in accordance with study requirements and applicable regulations.
Support day-to-day research operations across multiple ongoing clinical research studies within the Better Tomorrow Network.