CLINICAL RESEARCH SPECIALIST, SR
Requisition Number:: 128148
Date: Jun 16, 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.
Duke's Department of Obstetrics and Gynecology has an immediate need for a
part-time Sr. Clinical Research Specialist working with minimal risk
studies. (less than 20 hours)
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
- 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.
May train others in these policies and processes.
- 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 basic data for research studies. Scores tests and measures that do
not require interpretation, according to the protocol. 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
May assist with simple literature searches under supervision from PI or CRC.
Demonstrates a basic understanding of the elements of research study designs.
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, assists with ensuring 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
- Maintains Duke and project specific training requirements. Keeps current
with research updates by attending key external departmental meetings (i.e.
Research Wednesday, RPN, additional training, etc.).
- 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 with other study personnel as required for study
implementation and routine problem resolution.
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