Overview

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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 Date3 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