Organization is seeking a Chief, Clinical Research Management (CRM) to support the Infectious Disease Clinical Research Program (IDCRP) located in Rockville, Maryland. Organization provides scientific, technical, and programmatic support services to IDCRP. The Chief, CRM will provide expertise and knowledge in the development and execution of complex multicenter clinical study protocols, with particular focus on FDA-regulated clinical trials, while also supervising and mentoring the program’s CRM staff. These protocols are conducted by the Infectious Disease Clinical Research Program (IDCRP) at the Uniformed Services University of the Health Sciences (USU) in Bethesda, Maryland. The IDCRP is a collaborative research effort with the NIH National Institute of Allergy and Infectious Diseases (NIAID). Established at USUHS in 2005, this unique program aims to strengthen infectious disease clinical research in the US military. The IDCRP brings together a network of clinicians and research scientists at military treatment facilities and military bases who conduct observational and interventional research on a wide range of infectious diseases relevant to the military and the broader medical communities. IDCRP research protocols fall under one of seven research areas: acute respiratory infections, deployment and travel-associated infections, emerging infectious diseases/antimicrobial resistance, HIV infection, sexually transmitted infections, skin and soft tissue infections, and trauma-associated infections. Responsibilities:Demonstrates effective leadership in the areas of clinical research management, protocol development and operations, and regulatory affairs; actively engages and coordinates with IDCRP Directors and others to proactively plan and prepare clinical study teams for the Program’s expanding clinical research mission; works with Program leadership to develop and execute a strategic plan for IDCRP Clinical Research Management; serves as a subject matter expert consultant to Program investigators and staff as needed.Oversees operational development and execution of all IDCRP clinical research protocols; ensures operational success and timely accomplishment of protocol goals, including through effective leadership, management, and proactive identification and resolution of systems-based issues; conducts regular Research Area Review meetings to provide information to Program leadership; maintains knowledge and awareness of all IDCRP protocols and related documents.Proactively identifies and implements opportunities for standardization and best practices across the IDCRP network related to protocol development, documentation, and execution; enhances metrics-informed management of protocols within the IDCRP including managing the development, implementation, and training for the IDCRP Clinical Trials Management System (CTMS).Serves as the supervisor of Program Coordination Center (PCC) Clinical Research Managers and oversees site personnel serving the CRM role for specific protocols (working with supervising Site Manager); provides and ensures that all serving the CRM role have adequate and appropriate training; mentors CRM development.Ensures Program level consistency in protocol management and execution in accordance with Good Clinical Practice guidelines and other applicable regulations.Responsible for development and maintenance of clinical research and regulatory training materials related to the overall conduct of protocols in the IDCRP; leads teams of CRMs, CRCs, regulatory affairs personnel, and others to prepare these; oversees and provides initial and refresher training to new and existing employees, as well as to extramural personnel working on IDCRP protocols; ensures documentation of training is maintained and available, e.g. through IDCRP intranet or CTMS. Oversees protocol-specific training activities and documentation of these.Oversees and manages IDCRP quality management program to ensure regulatory compliance, data quality, and consistency; oversees and manages development and maintenance of IDCRP SOPs, ensuring availability, training, and documentation of compliance; coordinates with Data Coordination Center (DCC) Chief and others who have domain specific SOPs to ensure availability, training, and documentation of compliance.Supervises Program Regulatory Affairs Specialist; oversees and manages regulatory compliance processes including pre-IRB reviews, EIRB submissions, site specific requirements, FDA reporting, AE/UP reporting, and others.Responsible for effective communication, coordination, and management of IDCRP clinical research operations and regulatory matters with PCC, DCC, and site teams, Research Area and protocol teams, USU Human Subjects Protection Program, Institutional Review Board, protocol monitors, sponsors, auditors, and others as appropriate.Works directly with the Chief, Research Support and Operations (RS&O) and Chief, DCC to ensure effective, efficient, and timely accomplishment of IDCRP protocols and strategic plan; with Chief RS&O, oversees and supports Site Managers to these ends (working with supervising Site PI).Travels to clinical study sites and attends IDCRP, scientific and other meetings as required.Maintains clinical research professional credentials.Maintains knowledge of existing, new, and proposed federal and local regulations.Screens, interviews and selects applicants for CRM positions. Screens, interviews and assists with selection of applicants for non-CRM Program positions.Performs other assignments as required; serves as backup CRM as needed.Required Knowledge, Skills, and Abilities: Strong knowledge of federal (HHS, DoD, and FDA) and local regulations and policies pertinent to research involving human subjects; considerable experience in the development, conduct, and management of protocols for clinical trials and epidemiologic studies with prior experience in a clinical research environment; familiarity with clinical research methods, including studies utilizing randomized controlled trial, cohort, case-control, and case-series designs; working knowledge of clinical studies data management and analysis (primarily to serve as an effective liaison with other staff); experience with utilization of electronic medical records preferred; background in infectious disease clinical research preferred; prior supervision and mentorship of study personnel required; excellent verbal, written and interpersonal skills with experience in effective communication of research plans and findings; ability to lead initiatives to provide organizational process improvements and contribute to programmatic strategic planning. Minimum Education/Training Requirements: Master’s degree in Clinical Research or related field. Minimum Experience: 6 years of clinical research experience that includes FDA compliant clinical trials with particular emphasis on experience coordinating multicenter research. Physical Capabilities: Standing and sitting. Required Licenses, Certification or Registration: Clinical Research professional certification. Supervisory Responsibilities/Controls: 2 years of experience directly managing, supervising, and mentoring multiple clinical research management staff. Work Environment: Hospital, clinic or office environment with occasional travel to clinical study sites.
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