Clinical Research Coordinator - Peds
Occupational Summary
Coordinate and participate in clinical research studies led by Dr. Priya Kishnani and other principal investigator(s) in Pediatric Medical Genetics with studies of adult and children with rare metabolic diseases and genetic disorders including lysosomal storage diseases, glycogen storage diseases, and enzyme deficient pathways. Studies include clinical treatment trials, natural history studies, and disease registries. This position will collaborate with other research and clinical team members to conduct this research.
Operations:
-Screen, schedule, and consent participants for studies independently. -Maintain subject level documentation, including documentation of consent in electronic medical record for studies independently -Conduct and document visits for studies independently. -Collect, prepare, process, and ship research specimens. -Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. -Evaluate processes to identify issues related to recruitment and retention rates. -Assist with addressing and correcting findings from study monitoring and study audit visits. -Collect, complete, and submit Adverse Events Reports, according to institution and sponsor- specific prompt reporting requirements (timelines and forms) under supervision. -Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Ethics:
-Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation. -Maintain familiarity with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. -Understand that the safety of research participants is a priority.
Data:
-Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. -Score tests and measures, enter data, and complete Case Report Forms independently and accurately according to protocol. -Use required processes, policies, and systems to ensure data security and provenance. -Recognize and report vulnerabilities related to security of physical and electronic data. -Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Science:
-Conduct literature reviews independently. -Assist with development of research proposals or protocols. Leadership:
-Encourage and support colleagues in completing project work. -Assist research colleagues in identifying efficiencies and improving process. -Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. -Maintain Duke and project specific training requirements.
Study and Site Management:
-Collect information to determine appropriate feasibility, recruitment and retention strategies. -Ensure participant care expenses have appropriate financial routing in a timely manner. -Monitor financial study milestones and report appropriately. -Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. -Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). -Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. -Prepare for and take part in site initiation, monitoring, closeout visits, and document storage activities.
Communication:
-Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. -Participate in study team meetings. -Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. -Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Special Skills -Preference for candidate with previous regulatory experience in clinical trials and previous experience in rare genetic disorders. -Skilled in Epic Medical Record system and database software including RedCap.Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. 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.
Education
1.Completion of a Bachelor's degree 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Coordinate and participate in clinical research studies led by Dr. Priya Kishnani and other principal investigator(s) in Pediatric Medical Genetics with studies of adult and children with rare metabolic diseases and genetic disorders including lysosomal storage diseases, glycogen storage diseases, and enzyme deficient pathways. Studies include clinical treatment trials, natural history studies, and disease registries. This position will collaborate with other research and clinical team members to conduct this research.
Operations:
-Screen, schedule, and consent participants for studies independently. -Maintain subject level documentation, including documentation of consent in electronic medical record for studies independently -Conduct and document visits for studies independently. -Collect, prepare, process, and ship research specimens. -Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. -Evaluate processes to identify issues related to recruitment and retention rates. -Assist with addressing and correcting findings from study monitoring and study audit visits. -Collect, complete, and submit Adverse Events Reports, according to institution and sponsor- specific prompt reporting requirements (timelines and forms) under supervision. -Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Ethics:
-Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation. -Maintain familiarity with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. -Understand that the safety of research participants is a priority.
Data:
-Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. -Score tests and measures, enter data, and complete Case Report Forms independently and accurately according to protocol. -Use required processes, policies, and systems to ensure data security and provenance. -Recognize and report vulnerabilities related to security of physical and electronic data. -Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Science:
-Conduct literature reviews independently. -Assist with development of research proposals or protocols. Leadership:
-Encourage and support colleagues in completing project work. -Assist research colleagues in identifying efficiencies and improving process. -Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. -Maintain Duke and project specific training requirements.
Study and Site Management:
-Collect information to determine appropriate feasibility, recruitment and retention strategies. -Ensure participant care expenses have appropriate financial routing in a timely manner. -Monitor financial study milestones and report appropriately. -Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. -Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). -Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. -Prepare for and take part in site initiation, monitoring, closeout visits, and document storage activities.
Communication:
-Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. -Participate in study team meetings. -Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. -Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Special Skills -Preference for candidate with previous regulatory experience in clinical trials and previous experience in rare genetic disorders. -Skilled in Epic Medical Record system and database software including RedCap.Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. 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.
Education
1.Completion of a Bachelor's degree 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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