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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 the Magnet Award 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.

Research Manager

Full-Time

SUMMARY:

This individual will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will participate in all aspects of research management and quality assurance of data for the projects that are generated out of the Adult Joint Reconstruction Center. The candidate will play an integral role in day-to-day research activities, patient coordination, and ensuring efficient operations.

RESPONSIBILITIES:

(50% industry related study tasks, 25% research related quality assurance, 15% study coordination, 10% administrative support)

Industry:

• Serves as a liaison between HSS investigators and industry agencies and thought partners
• The Research Manager will play a pivotal role in the development and execution of comprehensive workflows and project tracking processes, ensuring compliance in clinical trials across all industry related studies for the ARJR service.
• This role will collaborate with interdisciplinary teams, fostering process improvement and emphasizing training clarity while maintaining high ethical standards
• Effectively oversee all elements of research trials within the designated study protocol including but not limited to contracting, budget, and milestone reporting.
• Formulate and establish workflows, protocols, and recommendations for staff and patients, ensuring adherence to quality and compliance standards
• Assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day-to-day managing and reporting of clinical trial program(s)
• Collaborate with clinical operations to develop and implement the overall data quality plan,
• investigator meetings, safety review committee, pre-study site selection visits, and communications to study sites, etc)

Research QA:

• Responsible for ensuring the accuracy and reliability of research data, creating and implementing quality assurance procedures, and conducting internal audits to identify areas for improvement
• Ensure compliance with applicable regulations, guidelines, and internal quality standards to maintain the integrity and reliability of clinical trial data and ensure patient safety
• Continuously improve quality systems and processes within the organization
• Conduct Audits: Plan and execute comprehensive audits of clinical trials. This includes auditing clinical trial master files, internal processes, investigator sites, contract research organizations (CROs), and other relevant entities to assess compliance with relevant regulations, guidelines, and standard operating procedures (SOPs)
• Host Audits/Inspections: Assist in hosting Sponsor audits and Regulatory Authority inspections
• Quality Assurance Documentation: Develop and maintain quality assurance documentation, including audit plans, audit reports, inspection readiness plans, and other relevant documents
• Ensure accurate and timely documentation of audit findings, observations, and corrective actions taken
• Training and Education: Provide training and guidance to internal staff and external stakeholders on quality assurance practices, regulations, and industry standards related to clinical research

Study Coordination:

• Contributes to all aspects of ARJR research including but not limited to the listed key areas:
• Assist in submission and study protocol development
• Recruitment process (conducts informed consent process)
• Assists in the development of Clinical Research Forms
• Data collection
• Leads, Initiates, and implement study logistics
• Assures that research is done in an accurate and efficient manner.
• Will be responsible for milestone reporting

Schedule and holds biweekly and monthly meetings for study protocols.

Ensures that all research related regulatory, institutional, and departmental compliance

requirements are met as appropriate.

Handles I.T. communications (requests) and generates reports from the registry as needed.

Facilitates completion of all internal documentation needed for research (IRB

applications, conflict of interest forms, data collection forms, etc.)

Manages data collection for research-specific 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 managing successful conduct of the study as well as research

assistants assigned to independent research studies.

Administrative Responsibilities:

• Contributes to recruitment process, oversees orientation, in-service training, and
• continuing education for Research Assistants (RA)/Clinical Research Coordinator (CRC)
• and manages the work flow of employees. Manages overall scheduling, progress, and overall responsibilities of designated team RAs.

MINIMUM JOB REQUIREMENTS:

Education/Training:

• Bachelors degree required, Masters preferred

Experience:

• 2 years of experience in clinical research required

Prior Epic experience

• Knowledge of Good Clinical Practice and Good Technology
• Practice
• Proficient use of computers and software
• Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus.