Share this Job


Requisition Number::  94188
Date:  Feb 1, 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 the globe.


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.


For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator(PI). Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.  Addresses and corrects findings. Maintains participant level documentation forall studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. Follows SOPs and strategies to manage and retain research subjects. 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., procedural and interventional studies).Provides oversight and training in screening activities to multiple study teams. Develops or helps develop SOPs. Collects, prepares, processes, ships,and maintains the inventory of research specimens, primarily those requiring complex procedures. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Conducts and plans for complex study visits. Participates in study team meetings.


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 or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. 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. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). Independently uses and implements technology to enhance productivity or process.


Assists with or contributes to the development of funding proposals. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Uses expertise in research design to provide significant contribution to protocols or research proposals. Contributes to the development of scientific publications or presentations.  Serves as an author on poster presentations or publications.


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 visits.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 complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast staffing needs. Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows. Prepares studies for closeout and document storage.


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 done efficiently. 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.


Research Activities: (Effort 60%)
Provided clinical research coordination and implementation for assigned pediatric clinical research projects within Pediatric Primary Care
Consent patients to assigned studies including but not limited to interventional, observational and retrospective research
Complete SOM and Sponso r electronic study management systems, including but not limited to iRIS, OnCore, Maestro Care
Collect and review clinical data as needed per protocol and enter into appropriate CRF/eCRF
Conduct initial study eligibility screening
Collectmand process research samples including biologics
Laboratory processing and shipping of research samples
Participate in team meetings, providing updates to PI and team


Regulatory Support: (Effort 20%)
Prepare regulatory submissions through approval for multiple studies and maintain regulatory files through the life-cycle of the study
Participate in monitoring visits, resolving all issues identified by the sponsor or its representative
Communicate with sponsor on behalf of PI's regarding all regulatory and study startup processes
Maintain Regulatory binders for assigned projects
Develops and submits documentation and information for IRB review
Communicates with the IRB staff and reviewers and handles issues appropriately
Prepares required progress reports for federally fund ed research projects


Data: (Effort 20%)
Ensure the accurate and timely collection of protocol identified data
Collect clinical dataas needed per protocol and enter into appropriate CRF/eCRF
Ensure data security and integrity in alignment with SOM requirements
Ensure timely entry of data into study established databases


Type of Research:
Participate is varied pediatric clinical research projects included those that are complex in nature. Pediatric clinical research working with patients with patients and their families.


Special skills:
Strong Communication and Organization skills; Experience with pediatric population and fluency in Spanish (spoken and writer) is preferred, but not required.


Minimum Qualifications

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 these values.


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 hiring department.


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh