Duke
Duke University School of Medicine, established in 1930, is one of the nation’s top medical schools. With a faculty of more than 2,500 physicians and researchers and a student body of over 1,300, it fosters an inclusive community of investigators, clinicians, and staff dedicated to advancing human health globally.
Operations
Assist with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering).
Prepare for study monitoring and audit visits.
Document participant‑level information for non‑complex studies (e.g., questionnaires, data registries, scripted studies) if outside of the EHR.
Recruit research participants according to study protocol.
Screen participants in person or over the phone for non‑complex studies or extract eligibility data from the EHR.
Employ simple procedures for collecting, preparing, processing, shipping, and maintaining specimen inventory.
Assist with establishing and maintaining study‑level documentation.
Schedule participants for research visits (excluding those requiring EHR access) and prepare necessary documents, equipment, and supplies in compliance with the protocol.
Conduct and document non‑complex visits and scripted testing or interviews.
Manage participant payment and participate in study team meetings.
Ethics
Recognize known potential adverse events and report them to the study team.
Conduct and document consent for participants in non‑complex or minimal‑risk studies as defined by the IRB.
Assist with the development of consent plans and documents for participants.
Under supervision, develop and submit documentation for IRB review of non‑complex studies (e.g., surveys, registries).
Data
Enter and collect basic data for research studies; score scripted or validated tests.
Correct and document incomplete, inaccurate, or missing data for non‑complex studies.
Run summaries and reports on existing data and ensure data security and provenance.
Submit study data to appropriate repositories and meet metadata specifications for data sharing.
Assist in merging datasets, recoding variables, and resetting scoring scales under supervision.
Prepare tables, data visualizations, and lay summaries to communicate study results to participants.
Assist in updating and developing reports on study progress for the PI and other study team members.
Execute testing processes after builds or project changes and conduct documentation for Part 11 projects.
Science
Assist with simple literature searches.
Develop elements of research protocols for simple studies (e.g., registries, survey studies) under guidance.
Contribute to scientific publications or presentations.
Study and Site Management
Attend or schedule site visits as directed.
Record participant accrual information and consent documentation for non‑complex studies in the clinical research management system.
Ensure ample supplies and proper functioning of equipment for studies with simple supplies or equipment.
Assist in preparing studies for closeout, including packing files, documenting storage, and shipping back extra supplies to the sponsor.
Leadership
Collaborate with the manager to identify improvement opportunities and develop a training plan.
Complete training courses and apply knowledge and skills; train others as appropriate.
Keep current with research updates by attending key external departmental meetings.
Communicate with other study personnel as required for routine problem resolution.
Education Work requires an associate degree.
Experience One year of relevant experience. Completion of the DOCR North Carolina state‑approved Clinical Research Pre‑Apprenticeship program may substitute for one year of required experience.
Degrees, Licensures, Certifications One year of relevant experience or a completed DOCR North Carolina state‑approved Clinical Research Pre‑Apprenticeship program may serve as a substitute.
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 provisions for requests for reasonable accommodation will be provided by each hiring department.
Nearest Major Market: Durham Nearest Secondary Market: Raleigh
Read more about Duke’s commitment to affirmative action and nondiscrimination at
hr.duke.edu/eeo .
#J-18808-Ljbffr
Operations
Assist with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering).
Prepare for study monitoring and audit visits.
Document participant‑level information for non‑complex studies (e.g., questionnaires, data registries, scripted studies) if outside of the EHR.
Recruit research participants according to study protocol.
Screen participants in person or over the phone for non‑complex studies or extract eligibility data from the EHR.
Employ simple procedures for collecting, preparing, processing, shipping, and maintaining specimen inventory.
Assist with establishing and maintaining study‑level documentation.
Schedule participants for research visits (excluding those requiring EHR access) and prepare necessary documents, equipment, and supplies in compliance with the protocol.
Conduct and document non‑complex visits and scripted testing or interviews.
Manage participant payment and participate in study team meetings.
Ethics
Recognize known potential adverse events and report them to the study team.
Conduct and document consent for participants in non‑complex or minimal‑risk studies as defined by the IRB.
Assist with the development of consent plans and documents for participants.
Under supervision, develop and submit documentation for IRB review of non‑complex studies (e.g., surveys, registries).
Data
Enter and collect basic data for research studies; score scripted or validated tests.
Correct and document incomplete, inaccurate, or missing data for non‑complex studies.
Run summaries and reports on existing data and ensure data security and provenance.
Submit study data to appropriate repositories and meet metadata specifications for data sharing.
Assist in merging datasets, recoding variables, and resetting scoring scales under supervision.
Prepare tables, data visualizations, and lay summaries to communicate study results to participants.
Assist in updating and developing reports on study progress for the PI and other study team members.
Execute testing processes after builds or project changes and conduct documentation for Part 11 projects.
Science
Assist with simple literature searches.
Develop elements of research protocols for simple studies (e.g., registries, survey studies) under guidance.
Contribute to scientific publications or presentations.
Study and Site Management
Attend or schedule site visits as directed.
Record participant accrual information and consent documentation for non‑complex studies in the clinical research management system.
Ensure ample supplies and proper functioning of equipment for studies with simple supplies or equipment.
Assist in preparing studies for closeout, including packing files, documenting storage, and shipping back extra supplies to the sponsor.
Leadership
Collaborate with the manager to identify improvement opportunities and develop a training plan.
Complete training courses and apply knowledge and skills; train others as appropriate.
Keep current with research updates by attending key external departmental meetings.
Communicate with other study personnel as required for routine problem resolution.
Education Work requires an associate degree.
Experience One year of relevant experience. Completion of the DOCR North Carolina state‑approved Clinical Research Pre‑Apprenticeship program may substitute for one year of required experience.
Degrees, Licensures, Certifications One year of relevant experience or a completed DOCR North Carolina state‑approved Clinical Research Pre‑Apprenticeship program may serve as a substitute.
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 provisions for requests for reasonable accommodation will be provided by each hiring department.
Nearest Major Market: Durham Nearest Secondary Market: Raleigh
Read more about Duke’s commitment to affirmative action and nondiscrimination at
hr.duke.edu/eeo .
#J-18808-Ljbffr