CLINICAL RESEARCH NURSE COORDINATOR

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes;  applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Ethics:
Identifies all AEs, and determines whether or not they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develop and submit documentation for IRB review in iRIS. Communicate with the IRB staff and reviewers and handle issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:
Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Demonstrates and applies open science practices and the FAIR data principals. Prepares data for deposit in repositories following publication or study closeout. Locates and follows repository-specific requirements to submit study data for sharing. May draft data sharing plans for clinical studies that ensure that data and documentation will support re-use. Understands and is able to identify when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices (E.g. IDC 10, CDISC, MedDRA, and WHODrug). Awareness of common data elements for research and understand how they would be applicable to their protocol(s). Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders. Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades and may conduct some testing and documentation for Part 11 projects.

Science:
Assists with or contributes to the development of funding proposals. Assists with simple literature searches. Using scientific proposals from the PI, develops elements of research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations.  Serves as an author on poster presentations or publications.

Study and Site Management:
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits.  May train others. Uses OnCore and eREG systems and system reports to manage research protocols. May train or oversee others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

Leadership:
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Description of Clinical Responsibilities:
Clinical responsibilities:
• Adult Medication
• Peripheral IV Insertion and Maintenance
• Alaris Pump Set up and Use
• Draw blood from arterial lines


Type of Research:
This will be a Neurology position. Parkinson's disease, Huntington's Disease, and Memory will be the main focus.

Special skills:
The candidate needs to have experience with IV placement.

Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe 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.