Job Summary Position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute. The position works closely with all Research Staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices.
Provides data management project support for multidisciplinary clinical research, including patient screening for study eligibility, obtaining informed consent and subject registration. Collects, verifies, organizes and records clinical information and data in case report forms. Abstracts data from necessary sources to complete all forms to the required quality. Performs the following data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding.
Assists in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Assists with subject follow-up for clinical protocols.
Works with the Research Staff to assist with the tracking of study progress and development of periodic status reports. Assist with preparation of annual reports and statistical information on clinical research as required by Institute, System, IRB or investigators.
Obtains all reports and submits data forms and pathology materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database to the Research Staff. Provides assistance as needed to peers to ensure that study deadlines are met. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing.
Maintains communication with the Research Staff regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements. Assists the Research Staff with the coordination and completion of submission packets for the IRB. Maintains working relationships with external customers (e.g. professional research organizations and physicians) to facilitate the submission of clinical investigational material to the appropriate regulating body. Performs other related duties as assigned.
Internal Number: 2018-15614
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