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Administrative Director of Clinical Research Operations
2 months ago
The Hospital for Special Surgery is seeking an experienced Administrative Director to lead the Clinical Review Panels (CRPs) and manage the methodology and feasibility review of proposed investigator-initiated research. This role will support the chair(s) and administrator of each CRP, and include statisticians from the Center for Biostatistics, to ensure that research studies are properly designed, have an appropriate statistical analysis plan, and can achieve their stated objective.
Key Responsibilities- Standardize and manage the methodological and feasibility review of research proposals submitted to HSS CRPs across a spectrum of musculoskeletal domains.
- Review research proposals submitted to HSS CRPs before submission to HSS IRB for ethical and safety review by addressing and/or clarifying any feasibility concerns including methodological or statistical decisions questions.
- Take responsibility to ensure high-quality proposals by managing content creation, review, and revision, for internal and external IRB reviews.
- Support Chairs and administrators of CRPs and assist with the creation and workflow of new CRPs.
- Identify qualified reviewers who have relevant subject matter expertise including machine learning and artificial intelligence when appropriate.
- Identifying regulatory requirement for investigational drug and/or device studies (IND/IDE).
- Maintaining familiarity with a range of funding mechanisms, including competitive grants, contracts, etc.
- When applicable, assist with statistical review and/or coordinating Data and Safety Monitoring plans and/or committees required for multi-site clinical trials involving treatment interventions.
- Assist with clinicaltrials.gov reporting requirements on behalf of HSS.
- Develop and implement policies and procedures and trainings for faculty and fellows on protocol development best practices; advise faculty, investigators, and administrators on preparation of application to CRP.
- Recommend process improvements in writing/editing protocols and consent forms.
- Create and implement systems and opportunities to promote effective communication, skills development, and navigation of organizational complexities among all team members.
- Attend monthly IRB meetings at HSS and liaison with commercial and/or SMART IRB when necessary.
- Review subject enrollment as part of the IRBs annual continuation with attention to diversity, equity, and inclusion.
- PhD/DPH degree in Biostatistics or a related field or equivalent experience preferred with formal training in research methods preferred.
- Demonstrated competencies in epidemiology, health policy and analytical skills Minimum of 15 years of experience contributing to clinical research in an academic medical center and experience should include at least 10 years of experience successfully leading complex projects or large teams.
- Analytical skills that include the ability to bring applied knowledge to analytic questions.
- Demonstrated competencies in computer software to track and support research project(s).
- Experience working with surgeon investigators.
- Experience with multiple deadlines including grant submissions.
- Prior Scientific Review and/or IRB committee membership a plus.
- Comprehensive knowledge of policies pertaining to research studies including ethics committee approvals (IRB).
- General knowledge of the principles of clinical research design and statistical analysis.
- Strong statistical programming skills using SAS, R, or other statistical software.
- Demonstrated history of peer-reviewed publications.
- Experience managing multiple tasks simultaneously covering a broad range of technical areas and adhering to deadlines.
- Excellent problem-solving skills with the ability to identify potential issues and problems early and be proactive to address them.
- Excellent organizational and administrative skills and exceptional oral and written communication skills.
- Project management, budget management, staff mentorship and training skills.
- Experience leading diverse, multi-generational, multidisciplinary teams.
- Experience managing effective teams and maintaining a positive work environment.
- Ability to work independently with limited oversight.
