Coordinator of Nursing (Duke University)

Position Overview CLINICAL RESEARCH COORDINATOR role within the School of Medicine and Duke Health system, supporting clinical research operations across interdisciplinary teams. The position involves managing complex, greater-than-minimal-risk clinical studies and working closely with Principal Investigators (PIs), sponsors, and regulatory bodies. Work Environment Located in Durham, NC (27710) Part of Duke University School of Medicine / Duke Health Embedded in a major academic medical center network Core Responsibilities Research Operations Manage clinical study workflows (including MTAs, CDAs, DUAs, DTAs) Support FDA regulatory submissions and compliance processes Manage investigational product (IP) storage, tracking, and administration Coordinate sponsors, IDS, CROs, and study stakeholders Handle recruitment, screening, and retention strategies Conduct protocol-compliant study visits Lead or support multidisciplinary research meetings Maintain documentation for complex clinical trials Support audit and monitoring visits Safety and Ethics Identify and report adverse events (AEs) Support informed consent processes (including complex studies) Prepare IRB submissions via iRIS Ensure compliance with ethical research standards Communicate risks, benefits, and study distinctions to participants Protect vulnerable populations in research settings Data Management and Analysis Collect, enter, and validate clinical research data Develop data collection SOPs and tools Ensure data quality and security compliance Map data across EHRs, EDC systems, and mobile platforms Apply FAIR data principles and open science practices Support qualitative and quantitative analysis using:Create reports, visualizations, and summaries SAS, R, SPSS, NVivo, Atlas.ti Scientific Contribution Assist with grant applications Conduct literature reviews Contribute to protocol development Support publications and presentations Site and Study Management Coordinate site visits and sponsor communications Use systems like OnCore, eREG, EHR tools Evaluate study feasibility Support study closeout and documentation Leadership & Professional Development Train and supervise team members Participate in committees and workgroups Contribute to operational improvement Demonstrate adaptability and organizational awareness Minimum Qualifications Associate’s degree required At least 2 years of clinical research experience (Apprenticeship program may substitute for 1 year) Skills & Tools Microsoft Office proficiency Clinical research systems (OnCore, iRIS, EDC tools) Strong regulatory and compliance understanding Data analysis software (SAS, R, SPSS, NVivo, Atlas.ti) Compensation USD $59,829 – $99,960 annually Based on experience, education, and institutional factors Key Theme This is a hands-on, high-responsibility clinical research operations role, combining: Patient-facing research coordination Regulatory compliance (FDA/IRB) Data management and analysis Multi-stakeholder project coordination If you apply for this position please say you saw it on Academicoxy

Position Overview

CLINICAL RESEARCH COORDINATOR role within the School of Medicine and Duke Health system, supporting clinical research operations across interdisciplinary teams.

The position involves managing complex, greater-than-minimal-risk clinical studies and working closely with Principal Investigators (PIs), sponsors, and regulatory bodies.

Work Environment

Located in Durham, NC (27710)
Part of Duke University School of Medicine / Duke Health
Embedded in a major academic medical center network

Core Responsibilities

Research Operations

Manage clinical study workflows (including MTAs, CDAs, DUAs, DTAs)
Support FDA regulatory submissions and compliance processes
Manage investigational product (IP) storage, tracking, and administration
Coordinate sponsors, IDS, CROs, and study stakeholders
Handle recruitment, screening, and retention strategies
Conduct protocol-compliant study visits
Lead or support multidisciplinary research meetings
Maintain documentation for complex clinical trials
Support audit and monitoring visits

Safety and Ethics

Identify and report adverse events (AEs)
Support informed consent processes (including complex studies)
Prepare IRB submissions via iRIS
Ensure compliance with ethical research standards
Communicate risks, benefits, and study distinctions to participants
Protect vulnerable populations in research settings

Data Management and Analysis

Collect, enter, and validate clinical research data
Develop data collection SOPs and tools
Ensure data quality and security compliance
Map data across EHRs, EDC systems, and mobile platforms
Apply FAIR data principles and open science practices
Support qualitative and quantitative analysis using:Create reports, visualizations, and summaries
- SAS, R, SPSS, NVivo, Atlas.ti