Job Information
HSS Manager, Research in United States
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
Neuromuscular, Research Manager
Full-Time
Responsibilities:
Oversees and conducts the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training).
Serves as primary contact for CDA and CTA, acting as a liaison between PI, CRO and sponsor:
Primary site contact for the negotiation of CDA, CTA and budget; responsible for tracking, processing and implementing clinical research budgets with sponsors for new studies and amendments.
Primary contact for clinical trial budget creation; oversees finances related to the clinical trials including budget, invoicing, salary sourcing, and financial reconciliations.
Directly manages day-to-day activities of multiple research coordinators, project assistants and volunteers in the department of Neurology.
Assists in recruiting, hiring, mentoring and implementing onboarding and trainings for new research staff. Completes developmental plans and performance management.
Manages data collection specific to research studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol. This includes the supervision of multidisciplinary teams involved in the successful conduct of the study as well as research assistants I and II and clinical research coordinators assigned to independent research studies.
Spearheads efforts to meet patient enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies.
Responsible for completing, tracking and monitoring IRB submissions for initial approvals, re-approvals, amendments and close-outs of all studies
Manages and executes IRB submissions for initial approvals, re-approvals, amendments, etc… Ensures timeliness and accuracy of submissions and no lapses in approvals for the study. Directs research coordinators in this effort as well.
Compiles and assists in analyzing and interpreting data in preparation for a presentation, sponsor/regulatory agency, publication, etc… with the assistance of project investigator
Performs advanced data queries when needed. Provides timely reports to Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project.
Participates in the design and development of new protocols, prospective databases, SOPs training protocols and new initiatives taken on by the department. This may include design of database and case report forms for investigator initated trials as well tools to facilitate data collection as requested for specific projects (calendars, schedules, tracking logs)
Represents the Principal Investigator in departmental audits as well as external audits performed by representatives of the sponsor for each clinical research project. Works closely with HSS internal monitor for guidance on these activities.
Conducts study specific team meetings(weekly) to ensure timely progress of patient enrollment and study activities.
Collaborates with the research team and research administration, as needed, to ensure that research subjects are treated in accordance with all mandated requirements. Ensures that standards regarding subject registration, protocol specific tests, and required documentation are adhered to. Reports deviations as appropriate and resolves issues when possible. Escalates issues to supervisor as needed.
Responsible for the handling, packaging, and shipping of dangerous goods under supervision and in compliance with State and Federal regulations. These specimens may include tissue, blood, dry ice, and chemicals. Certification in these procedures is required in accordance with the Federal Regulations. Knowledge of good clinical practice for the handling of specimens and blood may be required.
Manages all space, equipment and supply needs of the neurology research and neuromuscular clinic programs
Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
Assists /work with the development and implementation of independent research projects (completing all IRB submissions/follow-up) for non-research team (clinic team) members’ studies
Develops and implements ongoing quality improvement activities for research team. Ensures safe, efficient and quality research oversight, constantly updating practices based on industry standards
Qualifications
Requirements:
Experience in and understanding of research administration and clinical research, specifically, study implementation, management, monitoring, report preparation and protocol development required; management experience in busy academic Department preferred
Bachelor’s required; Master’s degree preferred
Clinical Research Coordinator Certification preferred
2+ years of clinical research experience and comprehensive understanding of the clinical trial process
Proficiency in Microsoft Office suite
Excellent oral and writing capability (knowledge of orthopedic terminology a plus)
Highly organized, keen attention to detail, ability to manage deadline, and prioritize multiple different studies and projects at once
Ability to interact effectively with patients, physicians and other clinical staff, and administrative leadership
Positive attitude toward work assignments, performance feedback, and interactions with co-workers
Other Requirements
#LI-Hybrid
Pay Range - Minimum
USD $75,000.00/Yr.
Pay Range - Maximum
USD $85,000.00/Yr.
Posted Date4 months ago(5/6/2024 5:33 PM)
Job ID2024-19397
LocationUS
CategoryResearch - All Openings
Emp StatusRegular Full-Time
Hours per Week35
ShiftDays