Clinical Research Coordinator
Participate in human subject clinical research studies conducted by principal investigators (PIs) of the Breast Clinical Research Program (Breast). The studies are overseen by the Oncology Clinical Research Unit (OncCRU) within the Duke Cancer Institute (DCI). Perform study-specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study- specific protocols, plans and processes.
Clinical Research Operations – Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation. Conduct and document visits, testing, and interviews according to study protocol, operational plans of clinical departments, and SOPs for all types of studies independently.
Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling.
Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.
Provide input for Institutional Review Board (IRB) documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation.
Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level.
Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports.
Study and Site Management – Participate in sponsor-required training. Coordinate operational plans for multiple research studies. Provide input for protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Assist with study budgets.
Prepare for, take part in, and potentially lead site initiation, monitoring, and closeout visits and document storage activities. Collect information to determine feasibility, recruitment and retention strategies.
Help maintain study's compliance with institutional requirements and other policies.
Data Management and Informatics – Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations to accurately enter data. Score tests and measures according to protocol. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Detect issues related to data capture, collection or management; suggest solutions.
Investigate incomplete, inaccurate, or missing data and documents to ensure accuracy and completeness of data. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. Recognize and report vulnerabilities related to security of physical and electronic data, suggest and implement solutions.
Communication and Team Science – Communicate professionally, efficiently, and effectively amongst coworkers. Recognize when others need to be brought into discussions and escalate appropriately. Expand on the ideas of peers or team members.
Ethics – 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.
Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications.
Leadership – Encourage and support colleagues in identifying efficiencies and improving process. Encourage career development by actively seek out continuing education opportunities and networking for self.
Mentor junior staff, including other Clinical Research Coordinators.
And other work as assigned.
Skills – Must be eager and willing to learn, organized, comfortable with patient discussion of studies, ability to communicate professionally with providers and peers, and able to meet deadlines.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
Requisition Number 401506587
Duke Entity MEDICAL CENTER
Job Code 1201 Clinical Research Coordinator
Job Family Level 52
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Shift First Day
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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).
The preferred candidate will have oncology or research experience, training, education or prior clinical trials coordination experience.
Will train the motivated candidate if no experience in research or oncology.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Auto req ID 105891BR