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Department: 480502 - UHR UTS/UNC Partnership
Location: Chapel Hill, NC
Essential Job Duties:
The Clinical Research Coordinator will support the department's first research network in the world dedicated to improving treatments and care for survivors of sexual assault.
This position will play an important role in supporting multi-site clinical research studies. The Clinical Research Coordinator will assist with study operations, participant recruitment and retention efforts, regulatory and study documentation, data collection and quality assurance activities, and coordination with collaborating clinical sites and research partners. The position requires strong organizational skills, attention to detail, professionalism, and the ability to work effectively with varied populations and interdisciplinary teams in a fast-paced research environment focused on trauma-informed care and survivor-centered research practices.
The Clinical Research Coordinator is responsible for the planning, organization, and conduct of multiple clinical research study protocols, including independently collecting and recording data, project administration, and communication with various stakeholders.
Other Work/Responsibilities:
Research Study Execution
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.
Regulatory and Compliance
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.
Participant Management
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.
Research Project Management
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.
Clinical Research Operations Support
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.
Required Qualifications:
Academic research experience, including data collection, documentation, and regulatory compliance support.
Ability to clearly, concisely, professionally, and effectively communicate verbally and in writing with staff, faculty, research participants, external partners, and individuals across organizations.
Strong organizational and project coordination skills with the ability to manage multiple research studies, timelines, and priorities simultaneously.
Strong professionalism, emotional maturity, and the ability to maintain composure in sensitive and high-stress environments are required.
Ability to maintain strict confidentiality and adhere to all human subjects research protections and ethical standards is essential.
Preferred Qualifications:
Strong written and verbal communication skills and the ability to work effectively and professionally with varied populations and interdisciplinary teams.
Ability to work independently while functioning collaboratively within a fast-paced research environment.
Knowledge of clinical research principles, Good Clinical Practice ( GCP ), and human subjects research protections.
Strong organizational skills and attention to detail with the ability to manage multiple competing priorities.
Ability to identify problems, implement process improvements, and support quality assurance activities.
Experience with participant recruitment, retention, study documentation, and regulatory compliance activities preferred.
Proficiency with Microsoft Outlook, Excel, and Word required.
Strong problem-solving skills and ability to adapt to evolving study and operational needs.
Experience working with sensitive or high-impact research topics is strongly preferred, including exposure to trauma-informed settings (e.g., sexual assault response or related services).
Experience supporting or interacting with individuals in acute or crisis situations, including emergency department or immediate post-incident settings, is highly desirable.
Required license or certification:
N/A
Position Number: 48SM63
AA/EEO Statement:
NC State University is an equal opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. The University encourages all qualified applicants, including protected veterans and individuals with disabilities, to apply. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-513-0574 to speak with a representative of the Office of Equal Opportunity.
If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or workatncstate@ncsu.edu.
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.
NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.
