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CLINICAL RESEARCH SPECIALIST, SR
Requisition Number:: 170885
Date: Jan 10, 2022
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.
Perform a variety of research, data, and clerical duties of a routine and
technical nature to support the conduct of clinical research under the
supervision of a Clinical Research Coordinator or similar Clinical Research
Units (CRU)/Oversight Organization (OO) designee. Participate in day-to-
day operations related to the collection, compilation, and documentation of
clinical research data and may train Clinical Research Specialists (CRS) in
1. Research Operations. Screens participants in person or over the phone for
non-complex studies (e.g., questionnaire, data registry, scripted) or may
collect information from the electronic health record (EHR) to assist study
team in determining eligibility. Recruits research participants according to
study protocol and follows standard operating procedures (SOPs) and
strategies to manage and retain research subjects. Schedules participants for
research visits and prepares necessary documents, equipment, supplies, etc.
Conducts and documents non-complex visits and scripted testing or interviews
and may manage participant payment. Maintains participant- level documentation
for non-complex (e.g., questionnaire, data registry, scripted) studies
outside of the EHR. Assists with establishing and maintaining study-level
documentation. May assist with study level documentation and approvals for
international studies. Under supervision, assists with managing
investigational products including arrival, storage, and handling
(requisitions, inventory, and reordering) and prepares for study monitoring
and audit visits. Independently employs simple procedures for collecting,
preparing, processing, shipping, and maintaining inventory of specimens.
Follows SOPs and participates in study team meetings.
2. Safety and Ethics. 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
3. Data. 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 and 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 when required.
4. Scientific Concepts. Assists with simple literature searches. Under
guidance, develops sections of protocols for simple studies (e.g.,
registries, survey studies). Provides some contribution to scientific
publications or presentations (no authorship).
5. Site and Study Management. As directed, attends or schedules site visits
and assists in preparing studies for closeout, (e.g., packing files,
documenting files for storage, shipping extra supplies back to sponsor).
Associates patients with studies in CRMS. For studies with simple supplies or
equipment, ensures that there are ample supplies and that equipment is in good
working order. Follows protocol-specific systems and process flows.
6. Leadership and Professionalism. 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 departmental meetings
(i.e. Research Wednesday, RPN, additional training, etc.). Communicates with
other study personnel as required for study implementation and routine problem
Required Qualifications at this Level
Work requires an Associate's degree.
One year of relevant experience. A Bachelor's degree may substitute for
Can easily use computing software and web-based applications (e.g., Microsoft
Office products and internet browsers).
The intent of this job description is to provide a representative and level of
the types of duties and responsibilities that will be required of positions
given this title and shall not be construed as a declaration of the total of
the specific duties and responsibilities of any particular position. Employees
may be directed to perform job-related tasks other than those specifically
presented in this description.
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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