Duke University

United States

October 12, 2021



Requisition Number:: 151749

Date: Sep 8, 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.

100% Grant Funded

This position is for a clinical research position with the Division of Pediatric Neurology and will support projects treating children with various neurologic disorders. Study portfolio will include industry and grant funded research, and may be complex in nature.

Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessaryand alerts appropriate parties. Knowledge able in regulatory and institutionalpolicies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May tra in others in these policies and processes. Under supervision, assists with managing investigational products including arrival,storage, and handl ing (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including supportfor 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. Follows SOPs and strategies to manage and retain research subjects.Recruits research participants according to study protocol. Screens participants for all studies, including those that are complex in natur e (e.g.,procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams. Develops or helps develop SOPs.Independently employs simple procedures for collecting, preparing, processing,shipping, and maintaining inventory of specimens. 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.

Ethics: Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in MaestroCare. 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 tosponsors and other agencies.

Data: Enters and collects data. Develops data entry or collection SOPs or too ls. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of datafor all studies , including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for 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.). May train or oversee others . Learns and uses new technology when required.

Science: Assists with or contributes to the development of funding proposals. 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. 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 sy stem and its reports to manage research participants' activities,calendars, tracking/marking financial milestones, and all aspects of studyvisits. 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. May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

Leadership: Proactively seeks opportunities to add relevant skills and certifications toown portfolio. Keeps current with research updates by attending key external offerings (i.e. Resea rch Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others.Serves on co mmittees and workgroups internal to Duke or externally in therapeutic are a 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 are a orclinical research to solve problems. Communicates effectively with others,regardless of reporting relationship, to accomplish shared work objectives.

Research Activities:

· Provided clinical research coordination and implementation for assigned pediatric neurology clinical research projects

· Consent patients to assigned studies including but not limited to interventional, observational and retrospective research

· Complete SOM and Sponsor electronic study management systems, including but not limited to iRIS, OnCore, MaestroCare

· Collect and review clinical data as needed per protocol and enter into appropriate CRF/eCRF

· Conduct initial study eligibility screening; review with PI

· Collect and process research samples including biologics

· Laboratory processing and shipping of research samples

· Participate in team meetings, providing updates to PI and team

Regulatory Support:

· 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 PIs regarding all regulatory and study startup processes

· Maintain Regulatory binders for assigned projects

· Develops and submits docum entation and information for IRB review

· Communicates with the IRB staff and reviewers and handles issues appropriately

· Prepares required progress reports for federally funded research projects

· Prepare draft budgets in support of study start up and CRU feasibility

· Coordinate submission of CRU scientific and financial feasibility review


· Ensure the accurateand timely collection of protocol identified data

· Collect clinical dataas needed per protocol and enter into appropriate CRF/eCRF

· Ensure data securityand integrity in alignment with SOM r equirements

Ensure timely entry of data into study establish ed databases Description of Clinical Responsibilities:

Type of Research: Therapeutic research protocols in pediatric neurology patients including those that are complex in nature.

Special skills: Pediatric research experience preferred but not required.

Minimum Qualifications Education

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