Clinical Research Coordinator, Children's CRU
Screen participants for all studies independently. Maintain subject level documentation for all studies independently. Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. Independently conducts and documents consent for participants in all studies, including those that are complex in nature/clinically relevant and/or require access to the EHR for documentation. May train or oversee others. Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information independently. 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: Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Be familiar 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. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.
Data: Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and 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. Run summaries and reports on existing data Follow SOPs for data QA.
Science: Conduct literature reviews independently Assist with development of research proposals or protocols. Summarize study results.
Leadership: 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: 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. Assist with study budgets. 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. Take part in site initiation and closeout meetings independently. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Prepare for closeout and document storage.
Communication: Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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.
Type of Research: Participate in a variety of research, data base, and clerical duties of a complex and technical nature for clinical trials and clinical research within Pediatric Medical Genetics Division involving studies with adult and children with rare metabolic diseases and genetic disorders.
Duke Entity MEDICAL CENTER
Job Family Level 52
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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Essential Physical Job Functions:
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- Completion of a Bachelor's degree
- Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)