Job Details
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.
This position is for a clinical research coordinator within the Division of Hematology & Oncology and will support projects treating children with hematologic disorders or cancer. The position will work with multiple investigators and other members of the team on clinical research studies. Biological samples will be collected and processed from children with these infections per protocol. This is a hybrid position with opportunities to work from home when work assignments do not require you to be on-site.
Type of Research:
Multiple studies in Pediatric Hematology and Oncology including those that are complex in nature
Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. 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. 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. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. Screens participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. Collects, prepares, processes, ships, and maintains the inventory of human 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). May train or oversee others. Conducts activities for study visits in compliance with the protocol. 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 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. May train or oversee others.
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. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Prepares data for deposit in repositories following publication or study closeout. Identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. Under supervision, performs de-identification on allowable data to Safe Harbor standards. 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. 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. Under supervision, develops validation and testing scripts for EDCs for new studies. Executes testing process after the completion of a build, or following any project changes or system upgrades. Follows policy related to 21 CFR Part 11 compliance, and under supervision may conduct some testing and documentation for Part 11 projects.
Science:
Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. 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:
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. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. 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.
Description of Portfolio Responsibilities:
Research Activities: (Effort 60%)
Provide clinical research coordination and implementation for assigned pediatric hematology & oncology clinical research projects
Consent patients to assigned studies including but not limited to interventional, observational, and retrospective research
Collect and process collected samples and prepare for cold storage or shipping per protocol.
Complete School of Medicine 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 clinical report form (CRF/eCRF)
Conduct initial study eligibility screening and 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
Collaborate with team and clinicians from Hematology, Oncology, and Pediatric Transplant and Cellular Therapies
Regulatory Support: (Effort 10%)
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
Develop and submit documentation and information for IRB review
Communicate with the IRB staff and reviewers and handle issues appropriately
Prepare required progress reports for federally funded research projects
Prepare draft budgets in support of study start-up and clinical research unit (CRU) feasibility assessments
Coordinate submission of CRU scientific and financial feasibility review documents
Data: (Effort 30%)
Ensure the accurate and timely collection of protocol identified data
Collect clinical data as needed per protocol and enter into appropriate CRF/eCRF
Ensure data security and integrity in alignment with School of Medicine requirements
Ensure timely entry of data into study established databases
Minimum Qualifications
Education
Completion of an Associate's degree
Experience
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.