The Division of Hematology at the University of British Columbia is seeking a Junior Research Coordinator for the Hematology Research Program (HRP). The Junior Research Coordinator will work with a team of research staff, administrative staff, physicians, nurses and liaise with other healthcare professionals to ensure research studies meet or exceed regulatory and institutional standards. This position requires frequent contact with physicians, nurses, pharmacists, and other hospital staff.
The Junior Research Coordinator may be the primary contact with the Research Ethics Board (REB), industry sponsors, government and other not-for-profit granting agencies, and regulatory bodies for research studies. Strong communication and interpersonal skills are essential.
Organizational Status
The Hematology Research Program (HRP) conducts phase I, II and III clinical trials, registries and other clinical research in patients with a variety of benign and malignant hematologic disorders. The Junior Research Coordinator will work under the supervision Research Program Manager, and Research Operations Manager of HRP, as well as principal investigators (PI) to fulfill research-related responsibilities in a professional and ethical manner.
Work Performed
· Conducts multiple studies from startup to closure under the supervision of Principal Investigators, Program Director, Research Program Manager, and Research Operations Manager.
· Ensures that all aspects of study are performed within International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Tri-Council guidelines, as well as institutional Standard Operating Procedures (SOPs).
· Assists with PI and Research Managers in study protocol development, grant application and regulatory submission. Assesses study feasibility, resource utilization and assists with budget development.
· Develops of study workflows and assists with identifying strategies to maximize study enrollment and improve efficiency.
· Obtains or assists PIs to obtain ethics and institutional approvals for investigator initiated and grant funded trials and sponsored clinical trials.
· Maintains trial related documents in regulatory/study binder ensuring accuracy and completeness, including but not limited to source documentation, case report forms, certifications, screening logs, and drug accountability logs.
· Identifies, consent, and recruits study participants, performs study specific assessments, educates and advises patients regarding protocol requirements.
· Communicates study procedures to clinical and research personnel; provides updates and support to other staff, as required.
· Coordinates with radiology, laboratory, pharmacy, health records, and nursing units as required by specific protocols.
· Oversees study progress, monitors patient safety, triages events appropriately as specified in study protocol.
· Provides timely reports to PIs, and Research Managers on study progress and any issues may affect the enrollment, timeline and financial status of studies.
· Collaborates with other Research Coordinators, Research Assistants and Students within the program and provides support as required.
· Performs other tasks and provides research support as directed.
Consequence of Error/Judgement
The Junior Research Coordinator should understand that:
a) The incumbent warrants that their performance in the conduct of clinical trials and research projects will strictly conform to appropriate regulations:
1) maintaining professional behaviour and respect for study subjects and staff;
2) the UBC Clinical Research Ethics Board
3) B.C. Privacy Act;
4) Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice; and
5)…
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