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Job Information
HSS Administrative Director-Clinical Review Panels (CRPs in New York, New York
Overview
How you move is why we’re here. ® Now more than ever.
Get back to what you need and love to do.
The possibilities are endless...
Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize
the abundant opportunities for growth and success.
If this describes you then let’s talk!
HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report . As a recipient of theMagnetAward for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.
Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise
Administrative Director-Clinical Review Panels (CRPs
Full-Time
Overview:
The primary responsibility of theAdministrative Director of the Clinical Review Panels (CRPs)is to manage the methodology and feasibility review of proposed investigator-initiated research at HSS, and regional sites involved in clinical research on behalf of HSS. At HSS, scientific review is conducted throughClinical Review Panels (CRPs)specific to one or more Departments/Divisions that review and approve research projects prior to submission to the Institutional Review Board (IRB). This position will support the chair(s) and administrator of each CRP, and include statisticians from theCenter for Biostatistics, to ensure that research studies are properly designed, have an appropriate statistical analysis plan, and can achieve their stated objective.
As a key member of the Clinical Research Institute at HSS, the Administrative Director will work CRP chairs and Investigators to address issues raised during scientific review prior to IRB submission.
Essential Tasks/Responsibilities
Standardize and manage the methodological and feasibility review of research proposals submitted to HSS CRPs across a spectrum of musculoskeletal domains (orthopedics, rheumatology, regenerative medicine, anesthesia, physiatry, etc.)
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 IRB’s annual continuation with attention to diversity, equity, and inclusion
Other duties as assigned
Qualifications
Education/Experience
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
Competencies
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.
Other Requirements
#LI-AG1
Pay Range - Minimum
USD $155,000.00/Yr.
Pay Range - Maximum
USD $175,000.00/Yr.
Posted Date5 days ago(6/24/2024 11:21 AM)
Job ID2024-19710
LocationUS-NY-New York
CategoryResearch - All Openings
Emp StatusRegular Full-Time
Hours per Week35
ShiftDays