Job Description
Record ID: 2529
Title of requester: Vlayka Liotcheva
Title of person who will manage position: ARPM
Name of person who will manage the position: Vlayka Liotcheva
Type of position: New position
Type of Research:
This position will manage the research portfolio of the Critical Care program in the Pulmonary Division. It will assist and provide oversight for the conduct of multiple research projects from initial proposal development and start-up, budget development and financial management, IRB and regulatory submissions and maintenance, database development, subject enrollment and data collection through closeout for a team of 10 investigators. In addition, it will have active contribution to manuscript preparations and poster presentations; it will also facilitate research collaborations with various institutions and organizations by leading large PI initiated multi-site studies with Duke serving as sIRB.
This position will oversee a team of four clinical research professionals supporting over 25 active research protocols, mainly PI initiated federally funded. One of the main responsibilities of this position will be the expansion of the Critical Care Research Program to DRH and DRaH.
Special skills:
Prior research experience in the field of Pulmonary medicine and federally funded projects is highly desired. Preferred experience in coordinating with multiple teams or departments to achieve study goals; experience with REDCap, Epic, OnCore, iRIS; excellent communication, organization and interpersonal skills; ability to multitask and work independently in a multidisciplinary academic environment
Description of Portfolio Responsibilities: (Effort 50%):
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.
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 issues in collaboration with the Principal Investigator (PI). Serves as an expert resource to the research program regarding regulatory and institutional policies and processes. Provides direction to the study team for preparation for study monitoring and audit visits. Provides oversight, training, and expertise to the study team 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. Serves as an expert resource for participant retention. Liaises with other resources at Duke to optimize retention rates. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program. Serves as an expert to the research program team members in the area of screening. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio. 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 the study team 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:
Ensures that study team members are appropriately identifying and documenting adverse event information. Provides oversight and training to the 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. Serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. 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 the research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to the study team who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
Data:
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. 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 and is aligned with FAIR data and open science principles. Serves as an expert resource to the research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for the research teams as relevant. Develops, oversees adherence, and trains to multiple study teams on the results reporting for patients and providers. Provides guidance based on CRU and institutional best practices. 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.
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. Independently develops protocols for multiple complex investigator-initiated studies within the research program. 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. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Makes feasibility recommendations for the research program. Develops and oversees processes to determine participation in trials. Oversees management of resources (staff, supplies, equipment) for the 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.
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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