Duke University
CLINICAL RESEARCH COORDINATOR
– Duke University
Located in Durham, NC, this full‑time, onsite position offers the opportunity to lead or participate in day‑to‑day operations across clinical research studies—screening and consenting participants, conducting protocol‑specific visits and tests, and ensuring meticulous documentation and data quality.
Duke University School of Medicine, established in 1930, is a world‑class academic medical center that values interdisciplinary collaboration and inclusive community.
Minimum Requirements
Completion of a Bachelor’s degree.
Completion of an Associate’s degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).
Responsibilities Clinical Research Operations
Screen, schedule, consent participants, and collect adverse event information across multiple studies.
Maintain subject‑level documentation, including consent in the electronic medical record.
Prepare documents, equipment, and supplies for research visits; conduct and document visits and protocol‑specific testing/interviews per SOPs.
Implement strategies to maintain recruitment and retention; evaluate processes and assist participants with individual needs.
Train junior staff in operational tasks as needed.
Specimen & Investigational Product Management
Collect, prepare, process, ship, and maintain inventory of research specimens; train others and improve handling systems.
Manage Investigational Products (IP): arrival, storage, handling, requisitions, inventory, accountability, reconciliation, and destruction.
Ensure compliance with IP handling systems for sponsored and investigator‑initiated protocols; track protocol‑ and subject‑level IP compliance.
Regulatory & Documentation
Prepare for monitoring and audit visits; assist with addressing findings.
Develop or provide input for IRB documents (consent forms, protocols, continuing reviews) and maintain study‑level documentation (regulatory binders, enrollment logs, patient registration).
Coordinate with Duke core services (IDS, Biobank) and recognize when agreements (e.g., MTAs, INDs) are required.
Ethical & Participant Safety
Maintain familiarity with ethical research conduct and safeguards for vulnerable populations; train junior staff on these principles.
Assist in designing studies with appropriate safety measures; develop or support safety/security documents (e.g., Data Safety Monitoring Plans).
Communicate risks and benefits of study participation clearly; recommend improvements to participant communications.
Data Management & Informatics
Use and train others in EDC systems; accurately enter and score data; complete CRFs/eCRFs per protocol.
Detect and resolve data issues; develop SOPs for data quality assurance; run queries, summaries, and reports.
Ensure data security and provenance; map protocol data flow and address vulnerabilities.
Recognize when data agreements or special regulatory requirements are needed and coordinate accordingly.
Scientific Concepts & Research Design
Understand and train others in basic study design concepts; conduct literature reviews.
Assist in developing proposals/protocols and identify shortcomings; coordinate with stakeholders for study design and implementation.
Leadership & Professionalism
Mentor and train junior staff; assign and review work; provide constructive feedback and performance plans.
Encourage team efficiency and career development; participate in committees, task forces, and scientific presentations/publications.
Apply professional guidelines and code of ethics; identify and elevate potential risks to participants, studies, or institutions.
Study & Site Management
Participate in sponsor‑required training; coordinate operational plans for multiple studies.
Develop protocol‑specific systems and documents (process flows, training manuals, SOPs, CRFs).
Support feasibility assessments, recruitment strategies, and financial routing for participant care expenses.
Preferred Qualifications
Phlebotomy experience.
Other Requirements
Ability to travel across multiple Duke site locations in the Raleigh–Durham area.
Position Details
Type: Onsite
Location: Durham, NC
Employment Type: Full‑time
Seniority Level
Entry level
Job Function
Research, Analyst, and Information Technology
Employment Type
Full‑time
Industries
Higher Education
Equal Employment Opportunity Duke 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, sex (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.
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– Duke University
Located in Durham, NC, this full‑time, onsite position offers the opportunity to lead or participate in day‑to‑day operations across clinical research studies—screening and consenting participants, conducting protocol‑specific visits and tests, and ensuring meticulous documentation and data quality.
Duke University School of Medicine, established in 1930, is a world‑class academic medical center that values interdisciplinary collaboration and inclusive community.
Minimum Requirements
Completion of a Bachelor’s degree.
Completion of an Associate’s degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).
Responsibilities Clinical Research Operations
Screen, schedule, consent participants, and collect adverse event information across multiple studies.
Maintain subject‑level documentation, including consent in the electronic medical record.
Prepare documents, equipment, and supplies for research visits; conduct and document visits and protocol‑specific testing/interviews per SOPs.
Implement strategies to maintain recruitment and retention; evaluate processes and assist participants with individual needs.
Train junior staff in operational tasks as needed.
Specimen & Investigational Product Management
Collect, prepare, process, ship, and maintain inventory of research specimens; train others and improve handling systems.
Manage Investigational Products (IP): arrival, storage, handling, requisitions, inventory, accountability, reconciliation, and destruction.
Ensure compliance with IP handling systems for sponsored and investigator‑initiated protocols; track protocol‑ and subject‑level IP compliance.
Regulatory & Documentation
Prepare for monitoring and audit visits; assist with addressing findings.
Develop or provide input for IRB documents (consent forms, protocols, continuing reviews) and maintain study‑level documentation (regulatory binders, enrollment logs, patient registration).
Coordinate with Duke core services (IDS, Biobank) and recognize when agreements (e.g., MTAs, INDs) are required.
Ethical & Participant Safety
Maintain familiarity with ethical research conduct and safeguards for vulnerable populations; train junior staff on these principles.
Assist in designing studies with appropriate safety measures; develop or support safety/security documents (e.g., Data Safety Monitoring Plans).
Communicate risks and benefits of study participation clearly; recommend improvements to participant communications.
Data Management & Informatics
Use and train others in EDC systems; accurately enter and score data; complete CRFs/eCRFs per protocol.
Detect and resolve data issues; develop SOPs for data quality assurance; run queries, summaries, and reports.
Ensure data security and provenance; map protocol data flow and address vulnerabilities.
Recognize when data agreements or special regulatory requirements are needed and coordinate accordingly.
Scientific Concepts & Research Design
Understand and train others in basic study design concepts; conduct literature reviews.
Assist in developing proposals/protocols and identify shortcomings; coordinate with stakeholders for study design and implementation.
Leadership & Professionalism
Mentor and train junior staff; assign and review work; provide constructive feedback and performance plans.
Encourage team efficiency and career development; participate in committees, task forces, and scientific presentations/publications.
Apply professional guidelines and code of ethics; identify and elevate potential risks to participants, studies, or institutions.
Study & Site Management
Participate in sponsor‑required training; coordinate operational plans for multiple studies.
Develop protocol‑specific systems and documents (process flows, training manuals, SOPs, CRFs).
Support feasibility assessments, recruitment strategies, and financial routing for participant care expenses.
Preferred Qualifications
Phlebotomy experience.
Other Requirements
Ability to travel across multiple Duke site locations in the Raleigh–Durham area.
Position Details
Type: Onsite
Location: Durham, NC
Employment Type: Full‑time
Seniority Level
Entry level
Job Function
Research, Analyst, and Information Technology
Employment Type
Full‑time
Industries
Higher Education
Equal Employment Opportunity Duke 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, sex (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.
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