Working with Dr. Ernest Sink, the Research Assistant will be responsible for maintaining a database which includes ensuring patients receive and answer questions pre and post op. The Research Assistant will work to improve follow up participation in research studies.
The Research Assistant will also work with statisticians to organize regular updates to outcomes for the purpose of quality assessment and patient information as well as work with electronic health records to assure key factors are in the research database such as complication data.
DUTIES AND RESPONSIBILITIES:
Clinical and Regulatory responsibilities:
- Performs informed consent on low risk studies (requires appropriate training).
- Collect data from medical charts/records, perform observational measurements for low risk studies, collection of clinical data from patients, and perform duties as put forth in the protocol.
- Under supervision, performs IRB submissions for initial approvals, re-approvals, amendments, etc…
- Compiles and assists in analyzing data in preparation for a presentation, sponsor/regulatory agency, publication, etc… with the assistance of project investigator
- Assists 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.
- 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.
- 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.
- A qualified candidate has the ability to communicate in an effective manner with management, clinical staff, external sponsors and patients at HSS. They may be asked to conduct procedures in the operating room including but not limited to blood processing, video, nerve conduction testing, photographs, applying devices and sensory testing.
MINIMUM JOB REQUIREMENTS:
- 0-2 years experience in clinical research
- Bachelor’s degree or working towards
- Scientific background
- Proficient use of computers and software
- Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus.