Clinical Research Coordinator
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Clinical Research Coordinator
Full-Time
Clinical Research Coordinator Position in Neurology at the Hospital for Special Surgery in New York, NY
SUMMARY:
Responsible for clinical and data management activities associated with clinical research at a service specific level. Performs data collection, data entry and analysis for studies as appropriate. We prefer applicants be comfortable working with patients and their families.
DUTIES AND RESPONSIBILITIES:
- Conducts the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training).
- Under supervision, monitors patients’ progress while on clinical trials via observation, clinical interactions and performance of study-specific assessments as outlined in protocols.
- 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.
- Spearheads efforts to meet subject enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies.
- Assists with IRB submissions for initial approvals, continuing reviews, amendments, etc… Ensures timeliness and accuracy of submissions and no lapses in approvals for the study.
- Ensures accuracy of personnel transcribing data from a paper case report form (CRF) into an electronic format.
- Performs data queries reconciliation 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).
- Compiles and assists in analyzing and interpreting data with the assistance of PI for reports to IRB, monitor NIH, NIH and/or sponsor, presentations and publications of various research projects.
- 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.
- 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.
- 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 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.