CLINICAL RESEARCH COORDINATOR

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

The Department of Family Medicine and Community Health at the Duke School of Medicine seeks a Clinical Research Coordinator (CRC) to manage multiple studies and support faculty investigators in clinical, community-engaged, and population health research. As a central resource, the CRC will coordinate study execution from development to close-out, ensuring regulatory compliance, participant engagement, data management, and reporting across qualitative, quantitative, and mixed-methods research in clinical, community, and health system settings.

The ideal candidate is an organized problem-solver with strong project management skills, experience managing multiple studies, and cultural competence. They should demonstrate adaptability and a commitment to inclusive, ethical research.

Clinical Research Operations (35%)

Study Development & Regulatory Compliance

• Assist investigators in study design and protocol development, ensuring feasibility and regulatory alignment.
• Draft and submit IRB protocols, amendments, and study-specific SOPs in compliance with institutional and federal regulations.
• Facilitate necessary agreements (e.g., MTAs, CDAs) in coordination with institutional offices.
• Develop study workflows, training materials, and manuals to ensure consistency across study teams.
• Ensure adherence to Good Clinical Practice (GCP), HIPAA, and participant safety guidelines.

Study Implementation & Coordination

• Oversee recruitment and retention strategies, addressing barriers to participation and optimizing engagement.
• Screen, schedule, and consent participants in clinical, behavioral, and intervention-based studies.
• Ensure proper execution of randomization, blinding, and intervention procedures where applicable.
• Conduct participant visits, structured interviews, and data collection activities in adherence to protocols.
• Train and oversee study staff in study procedures, data collection, and participant interaction.

Study Management & Quality Control

• Maintain study documentation and ensure compliance with protocol and institutional policies.
• Track study milestones, proactively identify operational challenges, and escalate issues as needed.
• Coordinate multidisciplinary study meetings, ensuring alignment across stakeholders.
• Prepare for and support monitoring visits, audits, and compliance reviews.

Ethical & Regulatory Compliance in Human Research (20%)

Regulatory Oversight & Ethical Standards

• Ensure research studies comply with federal regulations, institutional policies, and ethical guidelines, including GCP, FDA, OHRP, and NIH policies.
• Maintain IRB approvals, data use agreements, and research security protocols to ensure responsible research conduct.
• Assist investigators in implementing protocol-specific ethical safeguards, particularly for studies involving vulnerable populations.

Participant Safety & Risk Mitigation

• Oversee and conduct consent processes, ensuring that participants fully understand study procedures, risks, and benefits.
• Monitor adherence to protocols for adverse event detection, reporting, and mitigation, escalating concerns as necessary.
• Conduct internal compliance audits and prepare for external monitoring visits to verify adherence to safety and ethical guidelines.
• Assist in developing Data and Safety Monitoring Plans (DSMPs) and other protective measures for high-risk studies.

Education & Training in Ethical Research Practices

• Train and mentor study staff in research ethics, human subject protections, and regulatory compliance.
• Act as a resource for investigators and research teams on emerging ethical and regulatory challenges in human research.
• Develop study-specific materials and workshops to reinforce best practices in ethical participant engagement and data security.

Data Management, Analysis & Compliance (20%)

Data Collection & Integrity

• Oversee strategic, efficient, and culturally competent data collection aligned with study goals.
• Train and support research teams in Electronic Data Capture (EDC) systems (e.g., REDCap) and research tools.
• Develop standardized workflows, protocols, and case report forms (CRFs/eCRFs).
• Ensure compliance with data security regulations to protect integrity and privacy.

Data Quality, Compliance & Monitoring

• Ensure study data meets NIH, FDA, IRB, and institutional standards.
• Conduct data audits, quality checks, and provenance reviews to maintain accuracy and compliance.
• Identify and resolve data inconsistencies and missing values, implementing corrective actions.
• Maintain real-time tracking systems for enrollment, retention, and study progress.
• Apply data-driven decision-making to improve study efficiency and workflow.

Data Analysis, Reporting & Security Compliance

• Support quantitative and qualitative analysis for mixed-methods research.
• Use NVivo, Atlas.ti for qualitative and STATA, SAS, or R for statistical analysis.
• Develop visualizations, dashboards, and reports to track study progress.
• Coordinate data-sharing agreements (DUAs, DTAs) with institutional offices.
• Ensure compliance with data transfer agreements, safeguarding confidentiality and research integrity.
• Develop and enforce data security policies per institutional and federal guidelines.

Scientific Concepts & Research Design (15%)

• Independently review, synthesize, and apply scientific literature to inform research studies, manuscripts, and grants.
• Support the development of protocols from PI proposals and apply knowledge of research design and methods to assist in protocol development and regulatory submissions.
• Assist in preparing scientific presentations and publications, including data visualizations and study reports.

Study & Site Management (15%)

• Conduct clinical setting recruitment to align with study goals and patient populations.
• Organize and lead site visits across clinics, community settings, and hospitals.
• Assist in clinical research setup, including workflow development, staff coordination, and protocol adherence.
• Implement and oversee community-based recruitment, ensuring culturally competent engagement.
• Prepare for and support audits and regulatory inspections, ensuring institutional and federal compliance.
• Use clinical research management systems to track participant activities, enrollment, and progress.
• Manage study visits and participant data using electronic health records systems (e.g. EPIC/MeastroCare).
• Oversee protocol activities, including minimum footprint, SIP counsel, and compliance tracking.
• Ensure study teams adhere to institutional policies and research regulations.
• Develop and execute study closeout procedures, coordinating across multiple research teams.

Leadership & Professional Development (10%)

• Encourage and support colleagues in completing project work efficiently.
• Identify and implement process improvements to enhance research efficiency.
• Actively network and foster leadership opportunities within small research teams.
• Lead or participate in committees, task forces, and working groups related to research operations.
• Promote professional growth by seeking and encouraging continuing education opportunities for self and study team members.
• Contribute to scientific presentations and publications.

Special skills:

• Strong analytical and problem-solving skills.

• Ability to translate scientific concepts into regulatory documents and study protocols.
• Experience in data visualization, transforming investigator requests into effective figures.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced research environment.

Work requires a minimum of two years of relevant research experience (e.g., research, clinical, interaction with study population, program coordination, data analysis). A Bachelor's degree may substitute for 2 years required experience.

Preferred Qualifications: Master's or advanced degree in a discipline of public health, epidemiology, or related fields. Spanish language proficiency not required but a plus.

Minimum Qualifications

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age,color, disability, gender, gender expression, gender identit y, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration,innovation, creativity, and belonging. Our collective success depends onthe robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, a nd experiences flourishes.To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of allindividualsare respected, and that all voices are heard. All members ofour community have a responsibility to uphold these values.

Anticipated Pay Range:

Duke University provides an annual base salary range for thisposition as USD $ 58,656.00 to USD $98,000.00. Duke University considersfactors such as (but not limited to) scope and responsibilities of theposition; candidate' s work experience, education/training, and key skills; internal peer equity; as well as market and organizationalconsiderations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck.Duke provides comprehensive and competitive medical and dental careprograms, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at:https://hr.duke.edu/benefits/

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions thatrequire specific physical and/ or mental abilities. Additional information and provision for requests for reasonable accommodation willbe provided by each hiring department.

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke is an Affirmative Action/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, sex, sexual orientation, or veteran 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 essentialjob 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.