Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health . Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary: Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train o r mentor others in clinical research tasks. Provide and document professional nursing care for research participants.
Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. May help prepare FDA regulatory submissions in collaboration with the Office of Regulatory Affairs and Quality (ORAQ),including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. 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. Prepares for, provides support for study monitoring, and audit visits, including support for the reviewer. Addresses and corrects findings. 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 HER. Follows SOPs and strategies to m anage and retain research subjects. Recruits research participants accor ding to study protocol. Screens participants for complex studies (e.g., procedural and interventional studies). Collects, prepares, processes, s hips,and maintains the inventory of research specimens, primarily those requiring complexprocedures. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, e quipment, supplies, etc. Conducts and documents non/complex visits and s cripted testing or interviews. Manage participant payment. Leads meetings that are multidisciplinary, including those with complex objectives.
Ethics: Identifies all AEs, and determines wh ether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Conducts and documents co nsent for participants for all types of studies, including those that ar e complex in nature and/or require any orders in Maestro Care. Develops consent plans and documents for participants in a variety of studies. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Underst and 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. Recognize when patients are having difficulties with th is distinction. Develops and submits documentation and info rmation for IRB review. Communicates with the IRB staff and reviewers an d handles issues appropriately. Prepares and submits documents needed fo r regulatory and safety reporting to sponsors and other agencies.
Data: Enters and collects data using an EDC. Develops data entry or collection SOPs or tools. May provide oversight or trainingto study team members collecting or entering data. Ensures accuracy and complete ness of data for all studies, including those that are complex in nature . Recognizes data quality trends and escalates as appropriate. Follow da ta quality assurance procedures. Recognizes and reports security of phys ical and electronic data vulnerabilities. Maps a protocol's data flow pl an including data capture, storage, transfer, management, quality, and p reparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). Independently uses and implements technology to enhance productivi ty or process.
Science: Assists with or contributes to the development of funding proposals. Independently conducts literature sea rches and reviews. Using scientific proposals from the PI develops resea rch protocols. Demonstrates a basic understanding of the elements ofres earch study designs.
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, inc luding minimum footprint, calendars, tracking/marking financial mileston es, and all aspects of study visits. May Collects appropriate informatio n to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows.Prepares studies for closeout and document storage.
Leadership: Works with the manager to understand areas of oppo rtunity and develop a training plan. Takes training courses and applies the knowledge and skills. Keeps current with research upda tes by attending key external offerings (i.e. Research Wednesday, RPN, e vents outside of Duke, etc.) and applies the learned material to the job . May disseminate information to others. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrate s resilience and is adaptive to change. Communicates effectively with ot hers, regardless of reporting relationship, to accomplish shared work ob jectives.
Clinical responsibilities: *Ambulatory Medication Administration * Pediatric Medication *Adult Medication * Peripheral IV Insertion and Maintenance
Type of Research : Participate in a variety of research, data base, and clerical duties of a complex and technical nature for clinical trials and clinical research within Pediatric Medical Genetics Division involving studies with adult and children with rare metabolic diseases and genetic disorders.
Special skills : Experience with a pediatric population is an asset but not a requirement.
Minimum Qualifications Education 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) 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. Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).
Experience Twelve months of appropriate clinical nursing experience is required.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.
As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.