Hospital for Special Surgery Research Assistant I in New York, New York
Oversees the collection of data and entry; performs data analysis for studies within HSS. Studies will include retrospective trials, outcomes trials, non-interventional trials and low risk interventional trials.
The clinical studies assistant is part of a research team, compliant with all regulatory, institutional and departmental requirements.
DUTIES AND RESPONSIBILITIES:
Clinical and Regulatory responsibilities:
Oversees and conducts the informed consent process on low risk studies (requires appropriate training and certification of human research subjects training).
Manages data collection specific to research studies including but not limited to the performance of observational measurements for low risk studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol. This includes the supervision of multidisciplinary teams involved in the successful conduct of the study.
Spearheads efforts to meet patient enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies.
Under supervision from a clinical research coordinator or Sr. clinical research coordinator, 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.
Compiles and assists in final analyses of data in preparation for a presentation, sponsor/regulatory agency, publication, etc… with guidance from the study investigator
Assists the Principal Investigator in departmental audits as well as external audits performed by representatives of the sponsor for each clinical research project they manage. Consults 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
Proficient use of computers and software
Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus.
Hours per Week: 35
External Company Name: Hospital for Special Surgery
External Company URL: www.hss.edu
Street: 535 E 70th St