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Clinical Research Nurse Coordinator - Dermatology
Requisition Number:: 171708
Date: Jan 4, 2022
Durham, NC, US, 27710
Personnel Area: MEDICAL CENTER
This Position is Fully Grant Funded
School of Medicine:
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
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.
Duke University's Department of Dermatology has an immediate opening for a
Clinical Research Nurse Coordinator.
This position will work in the Dermatology Clinical Trial Unit on outpatient
trials and addresses various dermatological conditions with investigational
products that can be IV, SubQ, topical, or oral. Location will be at Duke
South Clinics as well as Duke Dermatology South Durham and Patterson Place.
Clinical responsibilities include ambulatory medication administration and
adult medication. Phlebotomy skills are preferred and this role may train or
oversee others in various processes.
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. 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 and 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 EHR.
Employs strategies to maintain retention rates. Evaluates processes to
identify problems with retention. Employs and may develop strategies to
maintain recruitment rates and evaluate processes to identify problems.
Escalates issues. Screens participants for complex studies (e.g., procedural
and interventional studies). Follows SOPs. Independently employs simple
procedures for collecting, preparing, processing, shipping, and maintaining
inventory of specimens.
Maintains study level documentation for all studies, including those that are
complex in nature (e.g., procedural and interventional studies). Conducts
and plans for complex study visits. May train staff. Participates in study
Identifies all AEs, and determines whether or not they are reportable.
Collaborates with the PI to determine AE attributes, including relatedness to
study. 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.
Assists with the development of consent plans and documents for participants.
Develops and submits documentation and information for IRB review.
Communicates with the IRB staff and reviewers and handles issues
appropriately. Prepares and submits documents needed for regulatory and safety
reporting to sponsors and other agencies.
Enters and collects basic data for research studies. May score scripted or
validated tests and measures. Independently corrects and documents incomplete,
inaccurate or missing data for non-complex studies.
Follows SOPs for quality assurance. Runs summaries and reports on existing
data. Follows required processes, policies, and systems to ensure data
security and provenance. In addition, recognizes and reports security of
physical and electronic data vulnerabilities. Learns and uses new technology
Demonstrates a basic understanding of the elements of research 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,
calendars, tracking/marking financial milestones, and all aspects of study
Uses required EMR functionalities to manage participants and study visits. .
Records basic protocol information in clinical research management system. For
studies with complex supplies or equipment, ensures that there are ample
supplies and that equipment is in good working order. May forecast staffing
needs. Ensures that studies are conducted in compliance with institutional
requirements and other policies. Follows protocol-specific systems and process
flows. Prepares studies for closeout and document storage.
Proactively seeks opportunities to add relevant skills and certifications to
own portfolio. Keeps current with research updates by attending key external
departmental meetings (i.e. Research Wednesday, RPN, additional training,
Navigates processes and people involved in Duke clinical research,
demonstrates the organizational awareness, and has the interpersonal skills
necessary to get work done efficiently. Demonstrates resilience and is
adaptive to change. 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 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
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
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