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Duke University Job Description: |
Job Title: CLINICAL RESEARCH COORDINATOR, SR |
Job Code: 1202 |
FLSA: E |
Job Level: 53 |
Revised Date: 10/13/2025 |
Job Family: JF 05 |
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.
Research Operations
Recognizes when agreements are necessary and directs teams to appropriate Duke offices for execution. Serves as an Investigational New Drug (IND) submissions expert resource; assists junior staff with FDA review or issues and provides oversight for documents, annual reports, and amendments.
Serves as an expert resource regarding regulatory and institutional policies and processes, including support for international regulatory compliance as needed.
Oversees management and documentation of investigational products (IP) for multiple 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 and 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.
Develops and oversees strategies to meet recruitment goals and improve retention; liaises with Duke resources as appropriate. Screens participants for all study types, including complex procedural and interventional studies, and provides oversight and training for screening activities to multiple study teams.
Develops, oversees adherence, and trains study teams in the use and development of standard operating procedures (SOPs). Creates and optimizes systems to manage research specimens and trains teams in specimen collection, processing, preparation, shipping, and maintenance. Provides expertise and training for complex study visits, tool development, and implementing operational plans.
Leads effective facilitation of team meetings to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
Safety and Ethics
Ensures appropriate identification and documentation of adverse events (AEs). Provides oversight and training to multiple study teams who conduct, document, and develop consent plans. Serves as an expert resource regarding conduct, documentation, and development of consent plans for participants; including liaising with and being knowledgeable about other Duke resources.
Provides oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare necessary documents for regulatory and safety reporting to sponsors and other agencies.
Trains teams in ethical conduct of research, including differentiating clinical care from research management and incorporating safeguards to protect vulnerable populations.
Data
Selects data capture methods and discusses advantages and disadvantages of each for study teams. Implements data capture methods at the unit, division, or departmental level. 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 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 Duke resources.
Assists 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 regarding 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 research teams, as relevant.
Develops, oversees adherence, and trains 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 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 or semi structured data, and rigorously explain findings in relation to the research context; May use 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
Develops substantial portions of funding proposals and grants and provides to the PI for approval. Assesses and determines solutions for operational shortcomings of proposals. Using scientific proposals from the PI, develops elements of research protocols for complex investigator initiated studies. Applies research design expertise to provide significant contribution to protocols or research proposals. 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 and develops processes to determine trial participation. Oversees site visits, operational plan implementation, and management of resources (staff, supplies, equipment) across multiple study teams or sites; may manage the budget for research studies.
Ensures studies are conducted in compliance with institutional requirements and other policies and develops and implements closeout procedures.
Leadership and Professionalism
Encourages staff to take part in professional development opportunities and provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).
Plays a key role on committees and workgroups. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study teams adoption of change in their working environment.
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.
Trains others to communicate effectively within teams and facilitates resolution of issues associated with teams or communication.
| 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.
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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.