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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 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
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
Clinical Research Coordinator will work most closely with three
Adult Reconstruction and Joint Replacement (ARJR) surgeons;
responsible for all aspects of research for the research team
including, but not limited to, data management activities
associated with clinical research at a departmental specific level,
assisting with protocol development, abstract and manuscript
writing, submitting new and continuing review IRBs, data entry and
coordinating with biostatistics team for analysis as appropriate.
He or she will be in compliance with all regulatory, institutional,
and departmental requirements; participate in all aspects of
research management and quality assurance of data for three ARJR
The successful applicant for the position of Clinical Research
Coordinator will be a highly motivated and organized individual who
is able to perform a variety of different tasks essential to the
implementation of a clinical study. He or she should be
knowledgeable of regulations regarding Human Subjects research. The
applicant must be able to multitask and prioritize research
projects. The Coordinator will have access to the medical records
of patients, and should appreciate this privilege, and maintain
strict confidentiality with all patient medical data.
A qualified candidate will have the ability to communicate in an
effective manner with management, clinical staff, external sponsors
and patients at HSS. The candidate will also have good
interpersonal and writing skills, as he or she will interface
directly with patients and medical staff on a routine basis. He or
she will be flexible, as the job description may evolve as studies
progress. The applicant must be available on site at the main
DUTIES AND RESPONSIBILITIES:
Clinical and Regulatory responsibilities:
- Conducts the informed consent process on studies as appropriate
(requires appropriate training and certification of human research
- Performs quality assurance audits on the registry. Ensures
accuracy of personnel transcribing data from paper case report form
(CRF) into an electronic format
- Compiles and assists in analyzing and interpreting data in
preparation for a presentation, sponsor/regulatory agency,
publication, etc with the assistance of principal investigator
- Prepare presentations, assist with abstract and manuscript
writing and submissions for academic conferences and journals.
- 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
- 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. Reports
deviations as appropriate and resolves issues when possible.
Escalates issues to supervisor as needed.
- Collaborates with the research team, Service level research,
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.
Administrative and Other Duties: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 and
Service Research Director for guidance on these activities.
- Participates in cross-functional process initiatives
- May have the opportunity to oversee industry-sponsored or
multi-centered studies. Act as a liaison between sponsor and
investigator; arranging site visits and submitting pertinent data
in a timely fashion. Would be responsible for all aspects of
carrying out such studies.
- May assist with enrollment and follow-up with the ARJR Registry
- May handle biological specimens (appropriate training will be
- 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
Education/Training: Bachelor's degree minimum; Medical students
Experience: 1-3years of clinical research experience, preferably
cited as co-author on abstracts/publications
Knowledge of Good Clinical Practice and Good Technology
Proficient use of computers and software
Preferred Skills: Knowledge of Orthopaedic and/or Rheumatologic
terminology is a plus
Computer literacy: MS Word, Excel, Powerpoint, RedCap, Epic, EDC
Experience in IND filings, NDAs and 510(k) filings is a plus
Statistical software such as R, SAS, SPSS or STATA is a plus