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CLINICAL RESEARCH COORDINATOR, SR
Job Title: CLINICAL RESEARCH COORDINATOR, SR
Job Code: 1202
FLSA: E
Job Level: 53
Revised Date: 10/13/2025
Job Family: JF 05
Occupational Summary
Leads day to day operations of multiple study teams conducting clinical research at Duke Health; performs a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; leads others in navigating the clinical research environment. Leads or participates in a variety of unit, department, or division level initiatives. Oversees the work of Clinical Research Coordinators (CRCs) and other research staff.
Work Performed
Research Operations
For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution.
Serves as an Investigational New Drug (IND) submissions expert resource. Assists junior staff to address U.S. Food and Drug Administration (FDA) review or issues. Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA.
Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.
May independently navigate conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies.
Oversees the management and documentation of investigational products (IP) for multiple study teams. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP.
Provides direction to multiple study teams to prepare for study monitoring and audit visits.
Maintains study level documentation for all studies. Provides oversight, training, and expertise to multiple study teams regarding study level and participant level documentation for all studies including those that are complex in nature (e.g., procedural and interventional studies) and require Duke University Heath System (DUHS) billing.
Serves as an expert resource for multiple study teams for participant retention and liaises with other resources at Duke to optimize retention rates.
For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals; provides training.
Screens participants for all types of studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training for screening activities to multiple study teams.
Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).
Creates, optimizes and oversees the systems used by multiple teams to manage research specimens. Serves as expert resource and trainer to multiple study teams in specimen collection, processing, preparation, shipping, and maintenance.
Serves as an expert resource and trainer to multiple study teams for preparing and conducting complex study visits, developing tools, and implementing operational plans.
Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
Safety and Ethics
Ensures that multiple study teams are appropriately identifying and documenting adverse event (AE) information.
Provides oversight and training to multiple study teams who conduct, document, and develop consent plans for participants for all types of studies, including those that are complex in nature and require any orders in Maestro Care. Serves as an expert resource with regard to conducting, documenting, and developing consent plans for participants in a variety of studies. This includes liaising with and being knowledgeable about other resources at Duke.
Provides oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
Serves as a resource to help staff and patients recognize the difference between clinical care and clinical management of research participants. Provides training in ethical conduct of research to multiple study teams.
Serves as expert resource to study teams, as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
Data
For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs electronic case report forms (ECRFs) and electronic data capture systems (EDCs) to collect data according to protocol.
Oversees the process of quality assurance (QA), data corrections, and queries used by multiple study teams, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain study teams.
Serves as a data corrections, queries, and QA expert resource within the Clinical Research Unit (CRU), department, or division; including liaising with and being knowledgeable about other related resources at Duke.
Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance.
Recommends and leads implementation of improved processes, policies, and systems to ensure data security and provenance.
Oversees the process of depositing data in repositories. Provides guidance on the selection of the appropriate repository, data governance requirements, and FAIR data and open science principles.
Serves as an expert resource to multiple study teams with regard to mapping data workflow. Predicts areas of vulnerability in the data workflow plan. Determines areas where data provenance may be compromised, and helps study teams work through solutions. Ensures that study teams are familiar with data workflow resources at Duke.
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams, as relevant.
Develops, oversees adherence, and trains to multiple study teams on reporting results to patients and providers. Provides guidance based on CRU and institutional best practices.
Benchmarks awareness of appropriate methods for monitoring study progress based on trial design.
May conduct rapid and and or in depth qualitative analyses or use statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis on a variety of data formats. May code quantitative data using statistical tools to prepare for analysis under direct supervision from Biostatistician and Principal Investigator (PI) or critically examine, interpret, and summarize findings for unstructured and semi structured data, and rigorously explain findings in relation to the research context; May include the use of qualitative data analysis software (e.g., NVivo, Atlas.ti) to code and categorize data.
May assist in developing a qualitative data analysis plan that aligns with study objectives and provide mentorship or education to others on qualitative data analysis tools. May provide mentorship or education to others on statistical tools for data cleaning and analysis for quantitative data.
Scientific Concepts
Independently develops substantial portions of funding proposals and grants and provides to PI for final approval. Assesses and determines solutions for operational shortcomings of proposals.
Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator initiated studies, across multiple PIs or study teams.
Uses expertise in research design to provide significant contribution to protocols or research proposals.
Independently conducts literature searches or reviews and provides significant contribution or leadership on accepted, peer reviewed publications or conference presentations.
Site and Study Management
Mentors, trains, and oversees activities related to how teams communicate with sponsors and contract research organizations (CROs).
Oversees use of systems and system reports to manage research participants activities, tracking and marking financial milestones, manage research protocol activities, and maintain current protocol information.
Makes feasibility recommendations for multiple study teams. Develops and oversees processes to determine participation in trials.
Oversees activities related to site visits, implementation of operational plans and management of resources (staff, supplies, equipment) across multiple study teams or sites. May manage the budget for research studies.
For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.
Develops and implements closeout procedures for multiple studies across multiple teams.
Leadership and Professionalism
Encourages staff to take part in professional development opportunities and provides opportunities for staff to attend key ext
Required Qualifications at this Level
Education/Training
Work requires an Associate's degree
Experience
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience.
Skills
Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
