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Research Coordinator

Company: Hospital for Special Surgery
Location: New York
Posted on: June 12, 2021

Job Description:

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 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 Coordinator

Arthoplasty Service

Full-Time 8am-4pm

SUMMARY:

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 surgeons.

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 hospital.

DUTIES AND RESPONSIBILITIES:

Clinical and Regulatory responsibilities:

  • Conducts the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training).
  • 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 protocol.
  • 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 as needed
  • May handle biological specimens (appropriate training will be provided)
  • 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

MINIMUM QUALIFICATIONS:

Education/Training: Bachelor's degree minimum; Medical students are preferred

Experience: 1-3years of clinical research experience, preferably cited as co-author on abstracts/publications

Knowledge of Good Clinical Practice and Good Technology Practice

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

Keywords: Hospital for Special Surgery, New York , Research Coordinator, Other , New York, New York

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