CLINICAL RESEARCH COORDINATOR
Requisition Number:: 151728
Date: Sep 2, 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 Aging Center
The Clinical Research Coordinator (CRC) will join a research team in the
Duke Center for Aging and the Duke Center for Research to Advance Healthcare
Equity. Ongoing studies are focused on community engagement and healthcare
equity. This research involves testing interventions to reduce disparities in
care and promote health equity for older African Americans with serious
This position will involve working with collaborators at multiple sites and
may require travel between clinics and offsite locations.
1. Screen participants independently. Demonstrate understanding of study
protocols and the ability to translate into project logistics.
2. Independently conduct and document consent for participants in all
studies, including those that are complex in nature/clinically relevant and/or
require access to the EHR for documentation.
3. Prepares for, coordinates, and actively participates in site visits.
4. Administer cognitive and mobility tests questionnaires to study
5. Maintain subject level documentation. Schedule participants and conduct
study visits independently.
6. Assist with the development of, and follow, protocol-specific systems and
documents including process flows, training manuals, standard operating
procedures, and case report forms.
7. Ensure that there are ample study supplies and that equipment is in good
8. Collect, prepare, process, deliver, and maintain inventory of research
9. 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.
10. Ensure participant care expenses have appropriate financial routing in a
timely manner. May monitor financial study milestones and report
appropriately. Coordinate with financial teams, PRMO, etc. and participate in
budget development as appropriate.
11. Uses clinical research management system and its reports to manage
research participants' activities, calendars, tracking/marking financial
milestones, and all aspects of study visits. Uses required EMR functionalities
to manage participants and study visits.
12. Uses clinical research management system and its reports to manage all
protocol activities, including minimum footprint, SIP counsel, and all aspects
of maintaining current protocol information.
13. Maintain study's compliance with institutional requirements and other
14. Oversee maintenance of Delegation of Authority Logs and training of key
personnel on study specific duties.
Take part in site initiation and closeout meetings independently.
15. Prepare studies for closeout and document storage.
16. May train or oversee others.
Safety and Ethics
1. Successfully conduct and document consent for participants for all types
of studies, including those that are complex in nature and/or require any
orders in Maestro Care or data entered into OnCore.
2. Work with the study team to develop DUHS IRB documents such as consent
forms, protocols, and continuing reviews.
3. Maintain protocol specific training requirements and develop solutions to
proactively ensure study team members' compliance with these training
4. Responsible for adherence to clinical research policies to ensure ethical
conduct and protect vulnerable populations. Understand that the safety of
research participants is a priority.
5. Assist with the development of Conflict of Interest (COI)/Data Safety
Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs) and Clinical
Quality Management Plans (CQMPs) and ensure study team compliance.
6. Recognize and employ the professional guidelines and code of ethics
related to the conduct of clinical research.
7. Develop and submit documentation and information for Institutional Review
Board (IRB) review. Communicate with the IRB staff and reviewers and handle
8. Identify all adverse events (AEs), and determine whether or not they are
reportable. Collaborate with the PI to determine AE attributes, including
relatedness to study.
9. Prepare and submit documents needed for regulatory and safety reporting to
sponsors and other agencies.
10. Responsible for adherence to clinical research policies to ensure ethical
conduct and protect vulnerable populations.
11. Communicate to research participants the difference between clinical
activities and research activities, and the risks and benefits of study
1. Use EDC systems and enter data accurately and may train others in these
tasks. Detect issues related to data capture, collection or management and
2. Use required processes, policies, and systems to ensure data security and
provenance. Recognize and report vulnerabilities related to security of
physical and electronic data. Independently investigate incomplete, inaccurate
or missing data/documents to ensure accuracy and completeness of data. Run
summaries and reports on existing data.
3. Assist with development of and follow SOPs for data quality assurance.
4. Recognize when data agreements are necessary.
1. Proactively seek opportunities to add relevant skills and certifications
to own portfolio.
2. Keep current with research updates by attending key external offerings and
apply the learned material to the job.
3. May disseminate information to others.
4. Serve on committees and workgroups internal to Duke or externally in
therapeutic area of research.
5. Demonstrate interpersonal skills to get work done efficiently.
6. Recognize and escalate organizational issues that could be optimized to
improve research processes.
7. Demonstrate resilience and is adaptive to change.
8. Use advanced subject matter expertise in the therapeutic area or clinical
research to solve problems.
9. Communicate effectively with others, regardless of reporting relationship,
to accomplish shared work objectives.
The ideal candidate will:
• Possess excellent verbal and written communication skills
• Demonstrate prior experience as research staff on human subjects clinical
research projects completing a range of activities, including recruitment,
consenting, data collection, etc.
• Exhibit ease communicating and relating to older adults, lay community
health workers, and diverse groups of stakeholders
• Possess effective recruitment and retention skills
• Demonstrate the ability to plan and prioritize workload to meet deadlines,
while planning and tracking status of different project components
• Be willing to be flexible in order to accomplish project goals
• Demonstrate flexibility and willingness to acquire new skills
• Demonstrate ability to work both independently and within a team with
excellence, dignity, and respect
• Possess ability to identify challenges to successful completion of project
and propose potential solutions
• Possess ability to work with and serve as resource for team members at sites
external to Duke
• Demonstrate excellent multi-tasking skills and attention to detail
• Experience with Maestro Care and OnCore is preferred but not required
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A
Bachelor's degree may substitute for 2 years required experience.
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