Background The Lupus Research Alliance (LRA) is the world s leading non-governmental, non-profit funder of lupus research. Over the past 20 years, the LRA has invested over $200 million in lupus research in more than 500 research and clinical studies. More recently, the LRA established an affiliate organization, Lupus Therapeutics (LT), which is responsible for the coordination, conduct and management of a North American-based clinical trial consortium, the Lupus Clinical Investigators Network (LuCIN). LT through LuCIN is currently conducting 11 Phase I through III clinical trials.
This is an exciting professional opportunity to join an initiative of critical importance to the lupus community from the ground up. Be part of a team of LRA/LT staff, academic and industry experts and individuals with lupus who envision and bring to life a unique infrastructure that builds and integrates a patient registry with a linked biorepository, and a data and analytics platform. This research information exchange platform, preliminarily referred to as Lupus Nexus, will expedite scientific discovery and clinical development, will accelerate precision medicine in lupus and will ultimately transform lupus care.
Position Summary The Lupus Nexus Director will be part of the Lupus Research Alliance s Research Department while working closely with Lupus Therapeutics colleagues and will be instrumental in the build and management of the Lupus Nexus. In collaboration with LRA/LT senior staff and key academic and industry partners the Lupus Nexus Director is responsible for the day-to-day activities required to design, launch and implement the Lupus Nexus. He/she will perform tasks necessary to coordinate diverse activities, enable the start of the patient registry, and help identify through open Requests for Proposals (RFPs) the most appropriate vendors for providing the specialized components for the Lupus Nexus including the registry database, clinician/researcher/patient portals, the centralized biobank, the data management and analytics platforms, and the high-performance computing infrastructure.
Responsibilities Manage collaborations between the LRA/LT, academic investigators, industry partners and the patient community to create the first lupus platform coalescing clinical samples/data, analytics and collaborations to accelerate lupus research and development Help and coordinate the activities of the Lupus Nexus Steering Committee Coordinate the activities of the individual Working Groups informing the build of the Lupus Nexus Ensure accurate, timely and thorough communication between the Steering Committee and the Working Groups Oversee the selection of the information technology platform components and manage its implementation and maintenance along with a LRA technology consultant Manage the vendor selection process from solicitations (preparation of RFPs) to evaluations (reviews of proposals) and contracts execution Work with LT staff and LuCIN investigators to coordinate the planning of a prospective, longitudinal clinical study conducted by LuCIN that will frame the registry component of Lupus Nexus Manage the business and financial planning for the Lupus Nexus including oversight of the budget Establish and oversee partnerships with diagnostic/genomic/other companies that support the goals and objectives of Lupus Nexus Collaborate with LT staff to ensure timely execution of all contracts (site contracts, Material and Data Transfer Agreements, etc.) and IRB/EC approvals Collaborate with LT staff to assist the clinical study operations specifically with the development/refinement of the clinical trial protocol and associated informed consent documents, preparation/execution of protocol-specific training materials and data collection tool training materials and with the conduct of site training Collaborate with LT staff and oversee Lupus Nexus staff to assist in clinical study monitoring and site management/monitoring efforts. Manage existing Lupus Nexus consultants and hiring/management of future Lupus Nexus staff in line with the operational requirements of the Lupus Nexus business plan Oversee Lupus Nexus staff or a vendor who will coordinate with study sites on biosamples/data queries resolutions, data revision, and assist with site re-training where necessary Oversee Lupus Nexus staff who will interface with study sites to help troubleshoot eCRF technology, biosamples/data collection, and/or other related issues Lead the development of the Quality management System (policies, protocols, SOPs, etc.) and oversee Lupus Nexus staff who manage these activities on a day-to-day basis Coordinate with LRA marketing/communications team to ensure the appropriate outreach and visibility of the Lupus Nexus for all relevant stakeholders Ensure patient engagement is at the forefront of all aspects of the Lupus Nexus Contribute innovations in all areas related to the successful function and operation of Lupus Nexus Identify and escalate issues appropriately to the LRA CSO and the LT ED Other job functions as assigned. YourMembership. Category: Science, Keywords: Clinical Research Scientist
Tagged as: management
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