Responsible for all data management aspects of clinical studies and efficiently performs all data management activities within assigned studies.
This data includes subject data retrieval in its various forms including but not limited to: outpatient and inpatient medical records such as physician notes, ER visits, medication records, inpatient admissions, operative reports, laboratory results, imaging reports, pathology results, interventional radiology reports, pill diaries, etc.
Ensures validity of research results through timely, accurate, secure, and complete data submission, generation of research charts, query resolution, reporting of deviations, creation of source documentation and case report forms, and assistance with the maintenance of adverse event logs.
Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms/EDC and that every data point can be verified within the source document.
Works collectively with the research team to enter subject data into Jefftrial and other applicable study management tools/systems for demographic information, study status dates, etc.
Works alongside research team and laboratory staff in the assistance in preparation of lab study supplies and shipment of patient specimens, as needed.
Coordinates external monitoring visits, reviews monitoring follow up letters, addresses open action items in collaboration with research team, and aids in the writing of the CAPA (Corrective and Preventative Action Plan).
Communicates with internal and external medical records departments to gather necessary data for data completion.
Collaborates with the Quality Assurance and Process Improvement Unit (QIU) with monitoring and auditing visits, and assists with the development and execution of CAPAs, as applicable.
Retains all study records in accordance with sponsor requirements and university policies and procedures.
Attends MDG meetings as well as other staff meetings as scheduled.
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Provides data management expertise to the team in identifying opportunities for improvement.
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