Clinical Research Nurse Coordinator
Clinical Research Nurse Coordinator
Type of Research
This position in the Duke Perinatal Research Center will include study activities for a wide array of obstetrics studies including, but not limited to drug trials, vaccine trials, observational studies, and on a occasion some gynecology studies involving contraception or other drugs. The ability to multitask and work as a team are extremely important. This position also requires that the employee be part on the team's on-call pool to cover sample collection and processing during after-hours situations.
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.
- Conduct and document consent for participants in a variety of studies independently.
- Assist with addressing and correcting findings from study monitoring and study audit visits.
- 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. 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. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.
- 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.
- Maintain Duke and project specific training requirements.
Study and Site Management:
- 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/closeout visits as directed. 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.
- 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.
- Ambulatory Medication Administration
- Adult Medication
- Peripheral IV Insertion and Maintenance
- Alaris Pump Set up and Use
- External Genital and Speculum Examination
- Vaginal Speculum Insertion and Removal
- Fetal Monitoring
Requisition Number: 401517528
Duke Entity: MEDICAL CENTER
Job Code: 1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level: 54
Full Time / Part Time: FULL TIME
Regular / Temporary: Regular
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas, an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
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. Must have current or compact RN licensure in the state of North Carolina. BLS required.
Twelve months of appropriate clinical nursing experience is required.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Experience in obstetrics is preferred but not required.
Auto req: ID106794BR