CLINICAL RESEARCH COORDINATOR
Requisition Number:: 134712
Date: Jul 14, 2021
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.
Job Title: Clinical Research Coordinator
Job Code : 1201 Job Level/Band: 52 SAP #:
Shift: First Hours per week: Group: DOCR
Participate in or lead day-to-day operations of clinical research studies
conducted by principal investigator(s) at Duke Medicine; perform a variety
of duties involved in the collection, compilation, documentation, and analysis
of clinical research data. May oversee the work of junior staff.
1.Clinical research operations. Screen, schedule, consent, and collect adverse
event information for participants in a variety of studies. Maintain subject
level documentation, including documentation of consent in the electronic
medical record. Prepare documents, equipment, or supplies for research visits.
Conduct and document visits and protocol- specific testing/interviews
according to study protocol, operational plans of clinical departments, and
Standard Operating Procedures (SOPs) for all types of studies independently.
Employ strategies to maintain recruitment and retention rates, and to assist
participants with individual needs. Evaluate processes to identify issues
related to recruitment and retention rates. May provide training to personnel.
Collect, prepare, process, ship, and maintain inventory of research specimens
and train others in these tasks; improve systems related to specimen handling.
Prepare for study monitoring or study audit visits. Assist with addressing and
Develop or provide input for Institutional Review Board documents such as
consent forms, protocols, and continuing reviews in a timely fashion. Maintain
or collaborate to maintain appropriate study-level documentation including
regulatory binders, enrollment logs, patient registration in the system of
Assist with management of Investigational Products (IP) including arrival,
storage, handling, requesting requisitions, inventory, reordering, drug
accountability, reconciliation, and destruction. Employ the required system
for handling, dispensing and documentation of IP for sponsored protocols. May
be responsible for determining the best methods for handling IP for
Investigator-initiated protocols, or coordinating with investigational
pharmacies as necessary. Maintain appropriate documentation. Track IP
compliance at the protocol-and subject level.
Collect, prepare, or process adverse event information per protocol, and
provide input for adverse event reports. May complete and submit Adverse
Events Reports, according to institution and sponsor-specific prompt reporting
requirements (timelines and forms).
Have familiarity with intellectual property rights, inventions patents, and
technologies. As appropriate, understand regulations related to
investigational products with sponsors. Coordinate with Duke core services
such as Investigational Drug Service (IDS), Biobank, etc. Recognize the need
for agreements (e.g., Material Transfer Agreements, Investigational New Drug
2.Ethical and participant safety considerations. Maintain familiarity 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. Train junior staff in the ethical conduct of
research, dealing with vulnerable populations, and provide guidance in
strategies used to maintain safety. May help in the design of studies so they
include specific safeguards to ensure ethical conduct and protect vulnerable
populations. May assist others will application of these principles.
May develop or assist with the development of documents related to safety and
security (e.g., Research Data Security Plans, Data Safety Monitoring Plans,
Conflict of Interest). Coordinate or assist with the coordination of efforts
of external monitoring boards.
Communicate to research participants, both orally and written, the difference
between clinical activities and research activities, and the risks and
benefits of study participation, in all study documents and research
participant communications. May recognize when patients are having
difficulties with this distinction. May make recommendations regarding how to
improve communications to help patients and staff understand the distinction.
3.Data management and informatics. Use and train others in Electronic Data
Capture (EDC) systems, technologies, and software necessary for study
operations. Enter data accurately. Score tests and measures according to
protocol and appropriate to role. Complete paper and electronic Case Report
Forms (CRFs and eCRFs) accurately and according to protocol. Assist with the
development of data collection documents to standardize process. Detect issues
related to data capture, collection or management; suggest solutions. May
independently design ECRFs and EDCs to collect data and select methods of data
capture and discuss advantages and disadvantages of each.
Investigate incomplete, inaccurate, or missing data/documents to ensure
accuracy and completeness of data; follow and develop, or assist with
development of, SOPs for data quality assurance. Adhere to processes and run
queries, summaries, and reports to monitor the quality of data. May develop QA
processes and oversee the creation and use of queries, summaries, and reports
for quality assurance purposes. May be responsible for recognizing trends
related to data quality and escalating as appropriate.
Use required processes, policies, and systems to ensure data security and data
provenance. Recognize and report vulnerabilities related to security of
physical and electronic data; suggest and implement solutions to
vulnerabilities related to security of data and data provenance.
Map protocol data flow. Predict areas of vulnerability for a protocol's data
flow plan. Determine areas where data provenance may be compromised. May be
responsible for determining solutions to vulnerabilities related to security
of data and data provenance.
Recognize when data agreements or special regulatory requirements are
necessary; may assemble the necessary parties to ensure that all agreements
are in place (e.g., data use agreements, data transfer agreements,
Investigational Device Exemptions (IDEs), etc.).
4.Scientific concepts and research design. Understand and train others in the
basic concepts of study design. Independently conduct literature reviews.
Assist with the development of or develop proposals or protocols; identify
shortcomings of proposals and protocols.
Identify various stakeholders (statistical, operational, etc.) to ensure
adequate design, implementation, and testing of study aims. May determine
operational/statistical elements needed for conduct of clinical and
5.Leadership and professionalism. Encourage and support colleagues to complete
project work. Assist research colleagues in identifying efficiencies and
improving process. Actively network and encourage leadership for staff within
a small work group. Successfully take part in or lead a committee, task force,
or ad hoc group. Encourage career development by actively seek out continuing
education opportunities for self and study team members. Participate in or
lead scientific presentations and publications.
Assign, review, and train others in various work responsibilities. Serve as a
mentor to junior staff, including other Clinical Research Coordinators. Employ
escalation and performance plans as needed. May be responsible for providing
constructive feedback to team members.
Recognize and employ the professional guidelines and code of ethics related to
the conduct of clinical research. Summarize and clarify for study teams, the
professional guidelines and code of ethics related to the conduct of clinical
research. May be responsible for identifying potential problems and risks to
the participant, study, investigator, team, sponsor, and institution.
Study and site management. Participate in sponsor-required training. Obtain
information for or coordinate operational plans for multiple research studies.
Develop protocol-specific systems and documents including process flows,
training manuals, standard operating procedures, and case report forms.
Ensure participant care expenses have appropriate financial routing in a
timely manner. Monitor financial study milestones and report appropriately.
Coordinate with financial teams, PRMO, etc. Assist with study budgets.
Prepare for, take part in, and potentially lead site initiation, monitoring,
and closeout visits and document storage activities. Collect information to
determine feasibility, recruitment and retention strategies. May make
recommendations to investigators and oversight organization(s).
Maintain study's compliance with institutional requirements and other policies
(e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social
Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and
training of key personnel on study specific duties.
6.Communication and team science. Prepare for and lead team meetings.
Recognize when others need to be brought into the conversation and escalate
appropriately. Expand on the ideas of peers or team member.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being
performed by individuals assigned to this classification. This is not intended
to be an exhaustive list of all responsibilities and duties required of
personnel so classified.
Required: 1.Completion of a Bachelor's degree 2.Completion of an Associates
degree plus a minimum of two years relevant experience (e.g., research,
clinical, interaction with study population, program coordination)
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Preferred: Registered Dietician Licensure
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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