CLINICAL RESEARCH SPECIALIST, SR
Requisition Number:: 125111
Date: Jun 10, 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.
Oncology Clinical Research Unit CRU
Breast Clinical Research Program BRST
Perform a variety of research, data, and clerical duties of a routine and
technical nature to support the conduct of clinical research for the Duke
Cancer Institute's DCI Breast Clinical Research Program BRST.
Participate in day-to-day operations related to the collection, compilation,
and documentation of clinical research data. The Oncology Clinical Research
Unit CRU oversees the conduct of research.
Operations, Study and Site Management – 20% Effort
Screen participants, conduct and document consent for participants in minimal
risk studies. Maintain subject level documentation. Schedule participants for
study visits. Prepare necessary documents, equipment, supplies, and interviews
according to study protocol and Standard Operating Procedures SOPs.
Follow procedures and documentation of study payment. Assist with maintenance
of study level documentation. Define source document.
Collect, prepare, process, ship, and maintain inventory of research specimens.
Communication – 15% of Effort
Write and speak clearly in a variety of settings and styles to convey messages
and ideas effectively. Respond to routine questions related to study protocol
and refer more complex questions or escalate issues to others as appropriate.
Communicate and coordinate with other study personnel as required for study
implementation and routine problem resolution.
Data – 55% of Effort
Use Electronic Data Capture (EDC) systems, technologies, and software to
accurately enter study data. Complete paper and electronic Case Report Forms
(CRFs and eCRFs) accurately and according to protocol. Run summaries and
reports on existing data.
Follow SOPs for data QA. Use required processes, policies, and systems to
ensure data security and provenance. Independently investigate incomplete,
inaccurate or missing data and documents to ensure accuracy and completeness
Recognize and report vulnerabilities related to security of physical and
Leadership – 5% Effort
Actively network. Actively and proactively participate in team meetings,
committees, task forces and ad hoc groups.
Encourage career development by actively seeking out continuing education
opportunities. Support colleagues in their project work; encourage completion.
Ethics – 5% of Effort
Recognize and employ the professional guidelines and code of ethics related to
the conduct of clinical research. Be familiar with the ethical conduct of
research, and safeguards needed when conducting research with vulnerable
populations. Understand that the safety of research participants is a
priority. Identify and explain the risk and benefits for a clinical trial.
Know and follow policies, standard operating procedures (SOPs), regulations
and protocol requirements that govern clinical research. Maintain Duke and
project specific training and certification requirements.
Basic Life Saving BLS certification from the American Heart Association or
Duke approved equivalent course is a requirement of this position.
And other work as assigned.
The above statements describe the general nature and level of work being
performed. This is not intended to be an exhaustive list of all
responsibilities and duties required. Employees may be directed to perform
job-related tasks other than those specifically presented in this
The intent of this job description is to be representative of the level and
the types of duties and responsibilities that will be required of this
position and shall not be construed as a declaration of the total specific
duties and responsibilities.
Bachelor's Degree is strongly preferred.
Qualifications Required At This Level
Work requires an associate 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).
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