RESEARCH PROGRAM LEADER

Operations: Works with institutional leaders and offices to handle complex issues related to contracts and agreements. Helps the research program resolve complicated contractual problems. 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. Serves as an expert resource across all study teams within the research portfolio for navigating regulatory compliance with international studies. Oversees the management and documentation of investigational products (IP) for multiple study teams/research program. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. 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. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s). 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, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. May train or oversee others. Provides expertise to research program team members in study level documentation. Provides oversight and training and lends expertise to research program. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. Prepares for and leads effective facilitation of research program meetings in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies. 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. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. 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 analyses on a variety of data formats and create data analysis plans. Prepares a wide variety of data formats for analysis. Provide support for various tools used for analysis and data management. Selects and implements data capture methods appropriate for the research program. Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. Manage and clean data in preparation for analysis under supervision. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Works with the CRU or departmental leadership to ensure that data is shared according to best practices and 

guidelines. Predicts areas of vulnerability in data flow across the research portfolio. Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis. Oversees implementation of data flow plans across the research portfolio. Ensures that study teams are familiar with and using data flow plan resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Benchmarks, awareness of appropriate methods for monitoring study progress based on trial design. Science: Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals. Provide guidance around FAIR data and open science implementation. Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams. Uses expertise in research design to provide significant contribution to protocols or research proposals. Provides significant contribution or leadership on accepted, peer-reviewed publication or conference presentation. Mentors others in this area. Study and Site Management: Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. 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. Makes feasibility recommendations for multiple study teams/research program. Develops and oversees processes to determine participation in trials. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Oversees implementation of operational plans across research program, including at multiple sites. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines. Leadership: Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the needs of staff retention, continuous improvement, and development. Keeps current with advances in the scientific area and considers the impact on the research program. Keeps self and team current with research updates by attending external offerings; applies learned material on the job. Plays key/leadership role on committees and workgroups. Navigates processes and people involved in Duke clinical research, demonstrates the 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 program through change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation 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. Description of Portfolio Responsibilities: (Effort 80%): Determines short- and long-term goals of the research program/shared resource in collaboration with investigator(s). Identifies research programs/shared resources gaps, constraints, needs, and milestones; helps develop operational sustainability plan and communicates with PI to plan necessary resourcing. Manages and documents all aspects of research project lifecycle including: initiation, planning, executing, monitoring, and closing. Directs project staff in the execution of project activities in accordance with project plan and timeline. Communicates project/program progress with all major stakeholders and adjust plans and timelines according to feedback. Manages the research program or shared resource operations. Monitors and adheres to the established budget, and assists with budget development. Ensures that institutional communications are shared with research program staff and faculty. Maintains communication within program and with other departments or offices to accomplish the program objectives. Manages, mentors, and/or trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan. Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.g., recruitment, consenting, study 

documentation, program evaluation, data capture, etc.). Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts. Represents research program or shared resource on behalf of the PI at internal and external meetings. The RPL will be managing Dr Syed research portfolio.Dr. Syed uses machine learning to recognize patterns in pathology and endoscopy images, particularly for diagnosing gastrointestinal diseases. Her lab studies the intestinal structure and function in patients with conditions like Crohn's disease, ulcerative colitis, and celiac disease. The RPL will work with Dr Syed to improve global health by enhancing diagnostics, and discovering new treatment strategies for childhood undernutrition Description of Clinical Responsibilities: Clinical responsibilities: • Type of Research: Will serve as Program Leader for GI division portfolio, in partnership with multiple collaborators. Special skills: Past experience as clinical research coordinator. Current leadership and management skills. Possess excellent writing and communication skills. Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record). • experience in coordination across global health partners, in particular Pakistan, Zambia, Uganda and Tanzania • experience working with global consortia • grant writing related to machine learning / artificial intelligence in medicine • wet bench skills with cell culture experience including derived from human tissue • experience in developing research experimental methods related to application of 'omic approaches in inflammatory gut disease in maternal & child health

Minimum Qualifications

Education

Completion of a Bachelor's degree

Experience

Work requires a minimum of four years of research experience (e.g., experience. research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related

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