Duke University
CLINICAL RESEARCH SPECIALIST, SR
Duke University, Durham, North Carolina, United States, 27703
CLINICAL RESEARCH SPECIALIST, SR – Duke University
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CLINICAL RESEARCH SPECIALIST, SR
role at
Duke University .
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About Duke University 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health – a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Operations Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex studies outside of the EHR. Follows SOPs to manage and retain research participants. Recruits participants according to study protocol. Screens participants in person or over the phone for non-complex studies or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study-level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, and supplies in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment.
Ethics Recognizes known potential adverse events, identifies them in the protocol or investigator brochure, and reports to the study team. Conducts and documents consent for participants in non-complex or minimal risk studies as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies, develops and submits documentation for IRB review.
Data Enters and collects basic data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes to ensure data security and provenance. Recognizes and reports physical and electronic data vulnerabilities. Learns and uses new technology when required. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision. Assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Executes testing processes after completion of builds or system upgrades. May conduct some testing and documentation for Part 11 projects.
Science Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies. Provides some contribution to scientific publications or presentations.
Study and Site Management Attends or schedules site visits. Records participant accrual information and consent documentation in the clinical research management system. For studies with simple supplies or equipment, ensures ample supplies and equipment in good working order. Follows protocol-specific systems and process flows. Assists in preparing studies for closeout, including packing files, documenting files for storage, and shipping extra supplies back to the sponsor.
Leadership Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies knowledge and skills. May train others in the skills learned. Keeps updated with research by attending key departmental meetings. Communicates with other study personnel as required for study implementation and routine problem resolution.
Type of Research Assist with study visits performing ophthalmic testing required by the protocol.
Special Skills Willingness to learn ophthalmology.
Knowledge, Skills and Abilities Can easily use computing software and web-based applications such as Microsoft Office and internet browsers.
Anticipated Pay Range The annual base salary range for this position is USD $20.76 to $31.44. Salary is based on scope, responsibilities, experience, education, and other factors. Duke also offers medical and dental care programs, retirement benefits, and a wide array of family‑friendly and cultural programs.
Minimum Qualifications Associate degree required.
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. Completion of the DOCR North Carolina state‑approved Clinical Research Pre‑Apprenticeship program may substitute for one year of required experience.
EEO Statement 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. All members of our community feel secure and welcome, and all voices are heard.
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.
Seniority Level Mid‑Senior level.
Employment Type Internship.
Job Function Health Care Provider.
Industry Higher Education.
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CLINICAL RESEARCH SPECIALIST, SR
role at
Duke University .
1 day ago – Be among the first 25 applicants.
About Duke University 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health – a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Operations Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex studies outside of the EHR. Follows SOPs to manage and retain research participants. Recruits participants according to study protocol. Screens participants in person or over the phone for non-complex studies or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study-level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, and supplies in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment.
Ethics Recognizes known potential adverse events, identifies them in the protocol or investigator brochure, and reports to the study team. Conducts and documents consent for participants in non-complex or minimal risk studies as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies, develops and submits documentation for IRB review.
Data Enters and collects basic data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes to ensure data security and provenance. Recognizes and reports physical and electronic data vulnerabilities. Learns and uses new technology when required. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision. Assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Executes testing processes after completion of builds or system upgrades. May conduct some testing and documentation for Part 11 projects.
Science Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies. Provides some contribution to scientific publications or presentations.
Study and Site Management Attends or schedules site visits. Records participant accrual information and consent documentation in the clinical research management system. For studies with simple supplies or equipment, ensures ample supplies and equipment in good working order. Follows protocol-specific systems and process flows. Assists in preparing studies for closeout, including packing files, documenting files for storage, and shipping extra supplies back to the sponsor.
Leadership Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies knowledge and skills. May train others in the skills learned. Keeps updated with research by attending key departmental meetings. Communicates with other study personnel as required for study implementation and routine problem resolution.
Type of Research Assist with study visits performing ophthalmic testing required by the protocol.
Special Skills Willingness to learn ophthalmology.
Knowledge, Skills and Abilities Can easily use computing software and web-based applications such as Microsoft Office and internet browsers.
Anticipated Pay Range The annual base salary range for this position is USD $20.76 to $31.44. Salary is based on scope, responsibilities, experience, education, and other factors. Duke also offers medical and dental care programs, retirement benefits, and a wide array of family‑friendly and cultural programs.
Minimum Qualifications Associate degree required.
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. Completion of the DOCR North Carolina state‑approved Clinical Research Pre‑Apprenticeship program may substitute for one year of required experience.
EEO Statement 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. All members of our community feel secure and welcome, and all voices are heard.
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.
Seniority Level Mid‑Senior level.
Employment Type Internship.
Job Function Health Care Provider.
Industry Higher Education.
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