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.

Type of Research:
This position will serve as the primary nurse coordinator for clinical studies in the Division of Hematology. The coordinator will conduct clinical research studies in the areas of benign Hematology and Sickle Cell Disease, as well as serve as back up for studies as needed. The nurse coordinator will be responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.), and will work with the Division Lead to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.). The person in this role must have organizational skills, communication skills, the ability to handle multiple assignments simultaneously, technology skills, medical terminology, and understanding of clinical medicine. They must be able to flex with the demand of work schedules and timelines. They must demonstrate excellent attention to detail. They must be able to manage, work with, and support multiple stakeholders with different practice styles in a productive manner, and willing to learn new and complex skills as needed. The nurse coordinator must be resourceful, able to work independently, and to problem-solve on a daily basis. The preferred candidate will have Duke clinical trial experience and a desire to expand their knowledge and to share knowledge in an academic setting.

Nursing Activities:

Plan, provide, supervise, and document professional nursing care utilizing the nursing processfor patients in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients. Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources.

Clinical Responsibilities:
* Adult Medication
* Peripheral IV Insertion and Maintenance

Operations:Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. 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. Maintains participant level documentation for all studies, including those 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 proce sses to identify problems with retention. May train or oversee others. E mploys and may develop strategies to maintain recruitment rates and eval uate processes to identify problems. Escalates issues. May train or over see others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or help s develop SOPs. May train or oversee others. Collects, prepares, process es,ships, and maintains the inventory of human research specimens, prim arily 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.

Et hics:
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 oth ers. Develops and submits documentation and informationfor IRB review. C ommunicates with the IRB staff and reviewers and handles 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. With supervision, responds to queries created by a CRO or the data manager. May assists with quality control and data cleaning as directed. 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 l ifecycle and management plans for multiple study protocols. Maps a proto col's data flow plan including data capture, storage, transfer, manageme nt, quality, and preparation for analysis (mayinclude data from EDCs, E HR, mobile apps, etc.). May train or oversee others. Innovatively uses t echnology to enhance a research process. May trainothers.

Science:
Assists with or contributes tothe development of fund ing proposals. Independently conducts literaturesearches and reviews. De monstrates and applies a basic understanding ofopen science practices an d the FAIR data principals. Using scientific proposals from the PI, deve lops elements of research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the developmen tofscientific 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 functional ities to manage participants and study visits. May train o thers. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocolinformation. May train others . Collectsappropriate information to determine whether thestudy 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, a nd may develop or implement, operationalplans (e.g. protocol-specific sy stems and documents including process flows). May train or oversee others. Prepares studies for closeout and document storage. May train or over see others.

Leadership:
Proactively seeks opport unities 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. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has th e interpersonal skills necessary to get work done efficien tly. Demonstrates resilience and is adaptive to change. Uses advanced su bject matter expertise in the therapeutic area or clinical research to s olve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Duke 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 thatal l members of the community feel secure and welcome, that the contributions of allindividuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Duke University provides an annual base salary range for this position as USD $63,692.00 to USD $102,937.00. Duke University considers factors such as (but not limited to) scope and responsibilities of theposition; candidate's w ork experience, education/training, and keyskills; internal peer equity; as well as market and organizationalconsiderations when extending an of fer.

Your total compensation goes beyond the dollars onyour paycheck.Duke provides comprehensive and competitive medical and dental careprograms, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn moreat: https://hr.duke.edu/benefits/

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions thatrequire specific physical and/or me ntal abilities. Additionalinformation and provision for requests for rea sonable accommodation willbe provided by each hiring department.

Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program . All registered nurses without a Bachelors degree in Nursing (or higher) are encouraged to enroll in anappropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in thestate of No rthCarolina. BLS required.Maintain compliance with required hospital and unit specific trainingcompetencies as well as an active RN status with the North Carolina Board of Nursing (NCBON). Exception:Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.

Twelve months of appropriate clinical nursing experience is required.

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.