School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:

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). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Provides training. 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. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Ethics:

Serves as an expert in AE identification and documentation, including liaising with and being knowledgeable about other resources at Duke. 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. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

Under direct supervision from Biostatistician and PI may perform basic analyses on structured data. 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. Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager. 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. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Documents and maintains documentation to facilitate data sharing during publication or study closeout. Identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. 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. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders. Science: Assists with or contributes to the development of funding proposals. Demonstrates and applies a basic understanding of open science practices and the FAIR data principals. Using scientific proposals from the PI, develops elements of research protocols. 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 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. May train others. 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. May train others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. 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:

Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.). Plays key role on committees and workgroups. 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.

 Clinical responsibilities: • Pediatric Medication

Type of Research: Pediatric oncology studies (COG), majority complex in nature.

Special skills: Pediatric and chemo experience preferred but not required.

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.