Overview
The Research Assistant works closely with other research staff and supports data entry for clinical trials. The Research Assistant has no supervisory responsibilities and works under direct supervision a supervisor of research programs, a research operations manager, or an education program manager. They cannot perform any tasks that by state or local law require a license to perform.
Responsibilities
Primarily supports subject management, such as, performs data entry in the Clinical Trial Management System (CTMS) and supports data entry needs of the study.
Adheres to the principles for the ethical conduct of research, and safeguards for protection of human subjects especially when conducting research with vulnerable populations.
Understands and prioritizes the safety of research participants.
Utilizes Electronic Data Capture (EDC) systems, technologies and software necessary for study operations.
Completes data entry related to test results and/or measures according to protocol, and appropriate to role. Completes electronic Case Report Forms (eCRFs) accurately and according to protocol.
Assists with investigating incomplete, inaccurate or missing data and or documents to ensure accuracy and completeness of data; follows Standard Operating Procedures (SOPs) for data quality assurance.
Appropriately utilizes standard processes, policies and systems to ensure data integrity, attribution, and security.
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Facilitate the request and shipment of archival pathology samples
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
Understand and demonstrates the professional guidelines and code of ethics related to the conduct of clinical research.
Completes all D-H and project-specific training requirements.
Communicates appropriately (written and orally) between stakeholders.
Assists with communications between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.
Performs other duties as required or assigned.
Qualifications
- - High School or equivalent required
- - Associates degree preferred
- - Previous research experience preferred
Required Licensure/Certifications