Lebanon, NH, 03766, USA
4 days ago
Research Assistant - Data Coordinator
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 - BLS certification required within 30 days of hire * Area of Interest:Secretarial/Clerical/Administrative * FTE/Hours per pay period:1.00 - 1.00 - 40 hrs/week * Shift:Day * Job ID:29848 Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dartmouth Hitchcock Medical Center and Dartmouth Hitchcock Clinics comply with applicable Federal civil rights laws and do not discriminate on the basis of race, color, national origin, age, disability, or sex. We do not exclude or treat people differently because of race, color, national origin, age, disability, or sex.
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