School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nationâ€™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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
This position may have an opportunity to work Remotely, Hybrid or In-Person. All Duke University remote workers must reside in one of the following states or districts: California; Florida; Georgia; Maryland; New York; North Carolina; South Carolina; Tennessee; Texas; Virginia or Washington, DC.
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. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Develops or helps develop SOPs. 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. Participates in study team meetings.
Under supervision may collect information about AEs, identified in the protocol or investigator brochure. 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.
Independently uses and implements technology to enhance productivity or process. May train or oversee others.
Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research 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 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. Ensures that studies are conducted in compliance with institutional requirements and other policies. Prepares studies for closeout and document storage. May train or oversee others.
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. Actively facilitates and leads multiple study team's adoption of change in their working environment. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Type of Research:
This position will support the IRB submission and maintenance process for the Division of Infectious Disease. The position will assist investigators and clinical research staff in writing consent forms and other documents consistent with Duke IRB requirements. The position will assist with sponsor visits and maintain study level documentation for the assigned study portfolio. The position will be supervised by the ID team Lead CRC, Sr. and will work in conjunction with the ID Team Regulatory Coordinator, Sr. who will manage the higher complexity regulatory.
Prefer experience with iRIS, good writing skills, as well as ability to utilize computer software easily.
Completion of an Associate's degree
Work requires a minimum of two years of research and/or regulatory experience. experience. A Bachelor's degree may substitute for 2 years of 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.
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