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Provides administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity.
Job Responsibility:
Assists with obtaining and preparing regulatory/essential documents throughout the duration of a study
Ensures documents and forms are compiled and submitted in a timely manner to the CRO, study sponsor or IRB as applicable
Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff
Assists with the contracting process, document preparation and execution
Interfaces with potential study subjects for the purpose of promoting participation in research studies
Assists with the screening of subjects for participation eligibility
Assists with and documents the obtaining of informed consent according to GCP
Assists with the timely and accurate data entry of study specific data into case report forms
Assists with addressing and resolving study sponsor questions, concerns, and queries
Processes and ships study specific lab specimens
Performs study specific procedures at protocol directed intervals
Provides general support for research projects as directed
Obtains and updates essential documents for specific studies
Attends clinical research-related training as required
Assists with study close-out activities
Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
Escalates issues to supervisor for resolution
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
Assists with various projects as assigned by direct supervisor
Requirements:
High School Diploma required
Certified Medical Assistant preferred
0-1 year experience in a medical setting and/or clinical research preferred
Willingness to obtain research specific training as needed
Must be able to meet deadlines for multiple concurrent projects
Ability to understand and follow study specific protocol and direction
Ability to understand a dialysis medical record
Attention to detail a must
Proficient with PCs and Microsoft Office applications
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