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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Clinical Trials, Quality/Risk Management, Regulatory Compliance, Research & Development
Type of Research:
Under the oversight of the DHVI Chief Medical Officer, the regulatory coordinator will direct and oversee regulatory compliance within DHVI specifically for basic research (not clinical research) in accordance with applicable Federal, State, and Local regulations; Standard Operating Procedures (SOPs) with Duke University and within DHVI; and evaluate specific protocols, plans, and processes as they relate to Human Subject Research funded by grants and contracts. Lead the day-to-day operations of regulatory submissions, amendments and renewals related to the needs of basic science research utilizing human samples. Lead the day-to-day operations of regulatory submissions, amendments and renewals related to the needs of basic science research utilizing human samples. Serve as the point person/lead within DHVI for regulatory compliance for basic research needs as it relates to the use and transfer of human subject materials. Work with the specimen manager and program team daily to approve all human specimens coming in or going out of DHVI from / to collaborators. Obtain IRB approvals and all documentation needed for the accessioning unit and specimen manager to ship samples and work with institutions as required to get MTAs or DUAs executed. Function as the compliance primary point of contact within DHVI for the submission of new basic or laboratory science grants that contain human subject's research. Responsible for leading human subjects' requirements for basic or laboratory science grant and contract submissions, working with program team and investigators. Point of contact for all JIT request pertaining to human subjects on grants or contracts. Track all HS training requirements for members of DHVI and ensure training is all up to date and correct staff are listed on all research protocols.
Operations: 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. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance. 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. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment.
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. 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: Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review RDSPs for multiple study protocols. Independently uses and implements technology to enhance productivity or process. May train or oversee others.
Science: Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Using scientific proposals from the PI, develops research protocols.
Study and Site Management: Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. For multiple study teams, 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.
Leadership: Encourages staff to take part in professional development opportunities. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). 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 across multiple study teams. Communicates with other study personnel as required for study implementation and routine problem resolution.
Required Qualifications at this Level
Education/Training: Completion of an Associate's degree. Master's degree preferred.
Experience: Work requires a minimum of two years of research and/or regulatory experience. A Bachelor's degree may substitute for 2 years of required experience.
Special skills: Can easily use computing software and web-based applications.
Internal Number: 59941
About Duke Human Vaccine Institute
The Duke Human Vaccine Institute (DHVI) continues to lead with cutting edge vaccine research against infectious diseases that impact global health. The investigators at the DHVI conduct basic and translational research to develop novel vaccines, therapeutics and diagnostics for diseases such as HIV-1, tuberculosis, influenza, syphilis, gonorrhea, cytomegalovirus, rotavirus, parainfluenza, zika flavivirus, plague and now SARS-CoV-2. Several DHVI investigator led basic science discoveries are currently being produced in Good Manufacturing Practice (CGMP) facilities for early phase vaccine trials.