CLINICAL RESEARCH NURSE COORDINATOR
CLINICAL RESEARCH NURSE COORDINATOR
ENDOCRINE ONCOLOGY RESEARCH
Participate in human subject clinical research studies conducted by principal investigators (PIs) of the Endocrine Team. The studies are overseen by the Oncology Clinical Research Unit (OncCRU) within the Duke Cancer Institute (DCI). Perform a variety of duties related to the implementation of human subject clinical research protocols, including but not limited to, collection, compilation,documentation, and analysis of clinical research data; and/or the coordination of the research study.
- 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 and train others in these tasks.
- Assist with management of IP.
- Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.
- May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
Maintain appropriate documentation.
- Track IP compliance at the protocol-and subject level.
- 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.
- Conduct and document consent for participants in a variety of studies independently
- Provide direction to study teams with preparation for study monitoring or study audit visits.
- Address and correct audit/monitor findings.
- Collect, prepare or process adverse event information independently.
- Complete and submit 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.).
- Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
- 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.
- Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs).
- Coordinate efforts of external monitoring boards.
- Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
- Map protocol data flow.
- Predict areas of vulnerability for a protocol's data flow plan.
- Determine areas where data provenance may be compromised.
- Use EDC systems and enter data accurately and train others in these tasks.
- Detect issues related to data capture, collection or management and suggest solutions.
- 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.Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
- 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.
- Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
- Make recommendations to investigative team.
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.
- Lead site initiation activities.
- Recognize components of operational plans and be able to obtain information needed to develop the plan.
- Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
- Develop and implement closeout procedures for multiple studies, unit, department, or division.
- 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.
- Perform other work as assigned.
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.
1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program.All registered nurses without a Bachelor's degree in Nursing (or higher)will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date.Experience: Twelve months of appropriate clinical experience is required.
This position requires and active NC RN License.
The preferred candidate will have oncology or research experience, training, education
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 identity, national origin, race, religion, sexual orientation, or veteran status.
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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.