An integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. Participates in all aspects of research management and quality assurance of data for a specific project(s) as assigned.
Supervises the day-to-day activities of the Research Assistant (RA) at a service/department level ensuring efficient operations. Responsible for data management activities associated with clinical research at a service specific level. Performs data collection, data entry and analysis for studies as appropriate.
DUTIES AND RESPONSIBILITIES:
Clinical and Regulatory responsibilities:
Oversees and conducts the informed consent process on studies as appropriate (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 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. This includes the supervision of multidisciplinary teams involved in the successful conduct of the study as well as research assistants I and II assigned to independent research studies.
Spearheads efforts to meet patient enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies.
Ensures accuracy of personnel transcribing data from a paper case report form (CRF) into an electronic format.
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. Directs research assistants in this effort as well.
Compiles and assists in analyzing data in preparation for a presentation, sponsor/regulatory agency, publication, etc with the assistance of project investigator
Performs advanced data queries when needed. Provides timely reports to Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project.
Participates in the development of new protocols, prospective databases and new initiatives taken on by the department. This may include independent design of databases and tools to facilitate data collection as required for specific projects (calendars, schedules, tracking logs)
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 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.
In collaboration with Clinical Research Administration (CRA), develops a training plan for newly hired Research Assistants (RA) in the department/service. Monitors the training progress of new hires and supervises the RA in the mentoring process. Responsible for the continued mentoring and education of assigned Research Assistants.
Prioritizes and schedules work activities to ensure that workflow is controlled and meets the need of the department. Communicates and maintains institutional/departmental policies, standard operating procedures, quality standards, improvement initiatives and external legal regulations/regulatory requirements.
Prepares all required internal reports on activity, on volume, and census reports 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:
3-5 years experience in clinical research
Proficient use of computers and software
Knowledge of Orthopaedic and/or Rheumatologic terminology is preferred but not required.
Hospital For Special Surgery