CLINICAL RESEARCH SPECIALIST, SR
Requisition Number:: 137256
Date: Jul 19, 2021
Durham, NC, US, 27710
Personnel Area: MEDICAL CENTER
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.
100% Grant/Sponsor Funded
Under supervision, assists with managing investigational products including
arrival, storage, and handling (requisitions, inventory, and reordering).
Under supervision, prepares for study monitoring and audit visits. Maintains
participant-level documentation for non-complex (e.g., questionnaire, data
registry, scripted) studies outside of the EHR. Follows SOPs and strategies
to manage and retain research subjects. Recruits research participants
according to study protocol. Screens participants in person or over the phone
for non-complex studies (e.g., questionnaire, data registry, scripted) or
may collect information from the EHR to assist study team in determining
eligibility. Follows SOPs. Independently employs simple procedures for
collecting, preparing, processing, shipping, and maintaining inventory of
specimens. Assists with establishing and maintaining study level
documentation. Schedules participants for research visits. Prepares necessary
documents, equipment, supplies, etc. Conducts and documents non-complex visits
and scripted testing or interviews. May manage participant payment.
Participates in study team meetings.
Recognizes known potential adverse events, identified in the protocol or
investigator brochure, and reports to study team. Conducts and documents
consent for participants in non-complex studies. These are typically
repositories, survey studies, simple observational studies and non-patient
studies that do not involve investigational products or devices. Cannot
consent for any studies that involve investigational products or devices or
require clinical research orders in Maestro Care (i.e., electronic health
record). Assists with the development of consent plans and documents for
participants. Under supervision, for non-complex studies (e.g., survey
studies and registries), develops and submits documentation and information
for IRB review.
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. 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.
Learns and uses new technology when required.
Assists with simple literature searches. Under guidance, develops sections of
protocols for simple studies (e.g., registries, survey studies).
Demonstrates a basic understanding of the elements of research study designs.
Provides some contribution to scientific publications or presentations (no
Study and Site Management:
As directed, attends or schedules site visits. Records participant accrual
information and consent documentation for non-complex studies in clinical
research management system. Records basic protocol information in clinical
research management system. 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 protocol-specific systems and process
flows. As directed, assists in preparing studies for closeout, (e.g., packing
files, documenting files for storage, shipping extra supplies back to
Works with the manager to understand areas of opportunity and develop a
training plan. Takes training courses and applies the knowledge and skills.
May also train others in the skills learned. 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 the interpersonal skills necessary to get
work done efficiently. 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.
Type of Research:
This position will support federal and industry funded research projects in
One year of clinical research experience with direct patient interaction;
knowledge of medical terminology and experience wit h EPIC and REDCap is
Work requires an Associate's degree.
One year of relevant experience. A Bachelor's degree may substitute for
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
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh