Duke University · 18 hours ago
CLINICAL RESEARCH COORDINATOR
Durham, NC
Full-time
Onsite
Entry, Mid Level
$60K/yr - $100K/yr
2+ years expDuke University School of Medicine is a top-ranked institution dedicated to advancing human health through research and education. They are seeking a Clinical Research Coordinator to support multiple research studies in the Reproductive Endocrinology and Infertility division, focusing on participant management, data collection, and compliance with regulatory standards.
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Responsibilities
Support multiple research studies in the Reproductive Endocrinology and Infertility (REI) division of OBGYN, conducted by multiple investigators
Screening for research studies, obtaining written consent, conducting study visits, maintaining participant level documentation, and collecting, processing, and transporting research specimens
Assist the Assistant Research Practice Manager with regulatory tasks
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs
Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants
Serve as the primary liaison with sponsors, IDS, and other parties as necessary
Follow protocol schema for randomization and blinding/unblinding
Prepare for and provide support for study monitoring and audit visits, including support for the reviewer
Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR
Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention
Employ and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalate issues
Screen participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies)
Provide oversight and training in screening activities to multiple study teams. Develop or help develop SOPs
Independently employ simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens
Maintain study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies)
Conduct activities for study visits in compliance with the protocol
Participate in study team meetings
Identify all Adverse Events(AE), and determine whether or not they are reportable
Collaborate with the Principal Investigator to determine AE attributes, including relatedness to study
Conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care
Assist with the development of consent plans and documents for participants
Develop and submit documentation for IRB review in iRIS
Communicate with the IRB staff and reviewers and handle issues appropriately. Prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies
Develop data entry or collection SOPs or tools
Enter and collect data
Provide oversight or training to study team members collecting or entering data. Ensure accuracy and completeness of data for all studies, including those that are complex in nature
Recognize data quality trends and escalate as appropriate. May develop tools for, and train others in, data quality assurance procedures
Follow required processes, policies, and systems to ensure data security and provenance. Innovatively use technology to enhance a research process
Assist in preparing tables, data visualizations, and lay summaries to communicate study results to participants
Assist in updating and may develop reports on study progress for the PI and other study team members and collaborators
Demonstrate a basic understanding of the elements of research study designs. Provide some contribution to scientific publications or presentations (no authorship)
Prepare for, coordinate, and actively participate in site visits. Communicate effectively with sponsors and/or CROs
Use clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits
Use required EMR functionalities to manage participants and study visits
Use OnCore and eREG systems and system reports to manage research protocols. For studies with supplies or equipment, ensure that there are ample supplies and that equipment is in good working order. May forecast effort needs
Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows)
Prepare studies for closeout and document storage
Proactively seek opportunities to add relevant skills and certifications to own portfolio. Keep current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and apply the learned material to the job. May disseminate information to others
Serve on committees and workgroups internal to Duke or externally in therapeutic area of research
Demonstrate interpersonal skills to get work done efficiently. Recognize and escalate organizational issues that could be optimized to improve research process. Demonstrate resilience and is adaptive to change
Use advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams
Communicate effectively with others, regardless of reporting relationship, to accomplish shared work objectives
Qualification
Required
Highly organized
Excellent attention to detail and communication skills
Ability to successfully balance multiple competing priorities
Comfortable in an Operating Room setting
Comfortable collecting, processing, and transporting biological specimens
Has a valid driver's license and reliable means of transportation
Completion of an Associate's Degree
Work requires a minimum of two years relevant research experience. A bachelor's degree may substitute for 2 years required experience
Knowledgeable in regulatory and institutional policies and processes
Applies appropriately in study documentation, protocol submissions, and SOPs
May train others in these policies and processes
Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants
Serves as the primary liaison with sponsors, IDS, and other parties as necessary
Follows protocol schema for randomization and blinding/unblinding
May train others
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer
Addresses and corrects findings
Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR
Employ strategies to maintain retention rates
Evaluate processes to identify problems with retention
Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems
Escalates issues
Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies)
Provides oversight and training in screening activities to multiple study teams
Develops or helps develop SOPs
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies)
Conducts activities for study visits in compliance with the protocol
Participates in study team meetings
Identifies all Adverse Events(AE), and determines whether or not they are reportable
Collaborates with the Principal Investigator to determine AE attributes, including relatedness to study
May train or oversee others
Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care
Assists with the development of consent plans and documents for participants
Develop and submit documentation for IRB review in iRIS
Communicate with the IRB staff and reviewers and handle issues appropriately
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies
Develops data entry or collection SOPs or tools
Enters and collects data
May provide oversight or training to study team members collecting or entering data
Ensures accuracy and completeness of data for all studies, including those that are complex in nature
Recognizes data quality trends and escalates as appropriate
May develop tools for, and train others in, data quality assurance procedures
Follows required processes, policies, and systems to ensure data security and provenance
Innovatively uses technology to enhance a research process
Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants
Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators
Demonstrates a basic understanding of the elements of research study designs
Provides some contribution to scientific publications or presentations (no authorship)
Prepares for, coordinates, and actively participates in site visits
Communicates effectively with sponsors and/or CROs
Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits
Uses required EMR functionalities to manage participants and study visits
Uses OnCore and eREG systems and system reports to manage research protocols
For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order
May forecast effort needs
Ensure that studies are conducted in compliance with institutional requirements and other policies
Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows)
Prepares studies for closeout and document storage
Proactively seeks opportunities to add relevant skills and certifications to own portfolio
Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job
May disseminate information to others
Serves on committees and workgroups internal to Duke or externally in therapeutic area of research
Demonstrates interpersonal skills to get work done efficiently
Recognizes and escalates organizational issues that could be optimized to improve research process
Demonstrates resilience and is adaptive to change
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives
Preferred
ACRP or SOCRA certification preferred
Benefits
Health insurance plans
Generous paid time off
Retirement programs with employer contributions
Tuition assistance for employees and their children
Company
Duke University
Duke University is a private research university providing undergraduate and postgraduate education in medicine and other disciplines.
10001+ employees
H1B Sponsorship
Duke University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (274)
2024 (232)
2023 (202)
2022 (195)
2021 (148)
2020 (121)
Funding
Current Stage
Late StageTotal Funding
$71.15MKey Investors
North Carolina Biotechnology CenterUS Department of EnergyGlaucoma Research Foundation
2023-02-17Grant· $0.11M
2022-09-19Grant
2022-03-09Grant· $0.05M
Leadership Team
Barry Myers
Professor and Director
Dan Ariely
Professor
Recent News
2026-01-11
2025-12-18
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