School of MedicineEstablished 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.Type of Research:· The position involves research in the pediatric population. Pediatric HospitalMedicine is increasing its participation in clinical trials. Current Trials are grant funded, and investigator initiated. CRC will assist in operationalizing the trials. Trials may be complex in nature.Operations:· For complex scenarios, recognizes when agreements are necessary within the research program.Facilitates the process by coordinating with study teams and appropriate Duke offices.· Prepares FDA regulatory submissions in collaboration with ORAQ, including development,submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issuesin collaboration with the Principal Investigator (PI).· May train or oversee others.· Serves as an expert resource to multiplestudy teams/research program regarding regulatory and institutional 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, includingsupport for the reviewer. Addresses and corrects findings. May train others. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Employ strategies to maintain retention rates. Evaluate processes to identifyproblems with retention. May train or oversee others.· Employsand may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others.· Screens participants for all studies, including those thatare complex in nature (e.g., procedural and interventional studies). Provides oversight and training in screening activities to multiple studyteams.· Follows SOPs. Collects, prepares, processes, ships, andmaintains the inventory of human research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains studylevel documentation for all studies, including those that are complex innature (e.g., procedural and interventional studies). May train or oversee others.· Schedules participants for research visits (excluding those requiring EHR access).· Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment.· Contributes to the effective facilitation of team meetings to achieve predetermined objectives.· May lead multidisciplinary meetings with various stakeholders.Ethics:· Identifies all AEs, and determines whetheror 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, includingthose that are complex in nature and/or require any orders in Maestro Care.· Develops consent plans and documents for participants in avariety 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 documentsneeded 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 basic data for researchstudies.· Scores tests and measures that do not require interpretation, according to the protocol.· With supervision, respondsto queries created by a CRO or the data manager. May assists with quality control and data cleaning as directed.· Independently correctsand documents incomplete, inaccurate or missing data for non-complex studies.· Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. Follows predetermined SOPs toassist in documenting and maintaining documentation to facilitated datasharing.· Knowledgeable about the use of data standard policies.Under supervision, performs de-identification on allowable data to SafeHarbor standards. Learns and uses new technology when required.· Assists in updating reports on study progress for the PI and other study team members and collaborators.Science:· Assists with or contributes to the development of funding proposals.· Assists with simple literature searches.· Demonstrates and applies a basic understanding of open science practices and theFAIR data principals.· Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).· Demonstrates a basic understanding of the elements ofresearch study designs.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.· Records basic protocol information in clinical research management system.· 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 areample supplies and that equipment is in good working order. Ensure thatstudies are conducted in compliance with institutional requirements andother policies.· Follows protocol-specific systems and process flows. Prepares studies for closeout and document storage. May train or oversee others.Leadership:· Proactively seeks opportunities to add relevant skills and certifications to ownportfolio.· Keeps current with research updates by attending keyexternal 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.· Navigates processes and people involved in Duke clinical research, demonstratesthe organizational awareness, and has the interpersonal skills necessary to get work done efficiently.· Develops and implements solutions that work within the existing leadership or organizational structure. Demonstrates resilience and actively facilitates the research programthrough change.· Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or fosterinnovation within the research program.· Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.Minimum QualificationsEducationCompletion of an Associate's degreeExperienceWork 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.
