CLINICAL RESEARCH COORDINATOR-Obstetrics and Gynecology
Requisition Number:: 134530
Date: Jul 9, 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 opening for a
Clinical Research Coordinator in their Urogynecology division.
https: // obgyn.duke.edu/divisions/urogynecology
100% Grant Funded
This position will develop, coordinate and manage clinical research studies
conducted by Duke Principal Investigators within the department of OBGYN,
division of Urogynecology. This role may train or oversee others.
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. Oversees the management and
documentation of investigational products (IP) for multiple study
Serves as an IP expert resource for study teams. Designs, implements, and
optimizes methods for handling IP. Prepares for and provides support for study
monitoring and audit visits, including support for the reviewer. Addresses and
corrects findings. Maintains participant level documentation for all studies,
including those that are complex in nature (e.g., procedural and
interventional studies) and/or require access to the Duke EHR. Employs
strategies to maintain retention rates.
Evaluates processes to identify problemswith retention . Employs and may
develop strategies to maintain recruitment rates and evaluate processes to
identify problems. Escalates issues. Screens participants for all studies,
including those that are complex in nature (e.g.,p rocedural and
interventional studies). Provides oversight and training inscreening
activities to multiple study teams. Develops or helps develop SOPs.
Independently employs simple procedures for collecting, preparing, processing,
shipping, and main taining inventory of specimens. Maintains study level
documentation for all studies, including those that are complex in nature
(e.g., procedural and interventional studies). Conducts and plans for
complex study visits. May train staff. Leads meetings that are
multidisciplinary, including those with complex objectives.
Identifies all AEs, and determines whether or not they are reportable.
Collaborates with the PI to determine AE attributes, including relatedness to
study. Conducts and documents consent for participants for all types of
studies, including those that are complex in nature and/or require any orders
in Maestro Care.
Develops consent plans and documents for participants in a variety of studies.
Develops and submits documentation and information for IRB review.
Communicates with the IRB staff and reviewers and handles issues
appropriately. Prepares and submits documents needed for regulatory and safety
reporting to sponsors and other agencies.
Enters and collects data. Develops data entry or collection SOPs or tools. May
provide oversight or training to study team members collecting orentering
data. Ensures accuracy and completeness of data for all studies, including
those that are complex in nature. Recognizes data quality trends and escalates
May develop tools for, and train others in, data quality assurance procedures.
Recognizes and reports security of physical and electronic data
vulnerabilities. May develop or review RDSPs for multiple study protocols.
Independently uses and implements technology to enhance productivity or
Assists with or contributes to the development of funding proposals. May
assist with simple literature searches under supervision from PI or CRC. Under
guidance, develops sections of protocols for simple studies (e.g.,
registries, survey studies). Demonstrates a basic understanding of the
elements of research study designs. Provides some contribution to scientific
publications or presentations (no authorship).
Study and Site Management:
Prepares for, coordinates, and actively participates in site visits.
Communicates effectively with sponsors and/or CROs. 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
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.Collects appropriate information
to determine whether the study team's participation in a specific trial is
feasible. May make recommendations. For studies with simple supplies or
equipment, ensures that there are ample supplies and that equipment is in good
Ensures that studies are conducted incompliance with institutional
requirements and other policies. Follows protocol-specif ic 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
Proactively seeks opportunities to add relevant skills and certifications to
own portfolio. Keeps current with research updates by attending key external
offerings (i.e. Research Wednesday,RPN, events outside of Duke, etc.) and
applies the learned material to the job.May disseminate information to others.
Serves on committees and workgroups internal to Duke or externally in
therapeutic area of research. Demonstrates interpersonal skills to get work
Recognizes and escalates organizational issues that could be optimized to
improve research process. Demonstrates resilience and is adaptive to change.
Uses advanced subject matter expertise in the therapeutic area or clinical
research to solve problems. Communicates effectively with others, regardless
of reporting relationship, to accomplish shared work objectives.
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