Clinical Research Coordinator
This is a 100% sponsored funded position.
- Screen participants for all studies independently.
- Maintain subject level documentation for all studies independently Schedule participants for study visits as directed.
- Prepare necessary documents, equipment, supplies, etc.
- Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies under direction.
- Follow procedures and documentation of study payment.
- Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
- Describe the various steps involved in handling IP. Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering
- Collaborate to 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.
- Conduct and document consent for participants in minimal risk studies.
- May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC.
- Assist with addressing and correcting findings from study monitoring and study audit visits.
- Oversee the collection of adverse event information Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
- Have familiarity with intellectual property rights, inventions patents, and technologies.
- As appropriate, understand regulations related to investigational products with sponsors.
- Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc. Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
- Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications.
- 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
- Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis 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.
Conduct literature reviews under the direction of the CRC, CRNC, or PI Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
- Encourage and support colleagues in completing project work.
- Assist research colleagues in identifying efficiencies and improving process.
- May serve as mentor to other staff.
- 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.
- 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
- 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.
Description of Portfolio and Clinical Responsibilities:
Type of Research
We are interested in reclassifying current CRC RN position to a non-licensed CRC in hopes of re-shaping our current model in the thoracic oncology clinic. This individual would assist the CRC RN with the day to day activities for active subjects such as scheduling and consenting to minimal risk trials which will help free up RNs. Would like to hopefully create a collaborative work environment with this new position.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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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.
- 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).
Clinical research experience would be advantageous good communication skills detail oriented
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