- 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, assists 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.
- Works closely with biostatisticians by preparing data sets for analysis.
- 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.
- Participates in cross-functional process initiatives
- Oversee industry-sponsored and/or multi-centered studies. Act as a liaison between sponsor and investigator; arranging site visits and submitting data to EDC and responding to queries in a timely fashion.
- Responsible for all aspects of prospective and retrospective studies.
- 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
- Bachelor's degree minimum
- 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
- 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
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Hospital for Special Surgery New York, United StatesOverview · 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 wo ...
Research Coordinator - New York, United States - Hospital for Special Surgery
Description
OverviewHow 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 enterpriseClinical Research Coordinator - Knee Service
Full-Time
Overview:
Clinical Research Coordinator will work most primarily with the Knee Service of the Adult Reconstruction and Joint Replacement (ARJR) Division.
The CRC will be responsible for all aspects of research for the Knee Research 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 ARJR surgeons on the Knee Service.
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.
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.Clinical and Regulatory responsibilities:
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.
Education/Training:
Experience:
Preferred Skills:
* formal Cover Letter, current resume/CV and three professional reference contacts
Other Requirements
#LI-Onsite
Pay Range - Minimum
USD $51,500.00/Yr.
Pay Range - Maximum
USD $65,000.00/Yr.
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