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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 including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms
Under close supervision, 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 as necessary to ensure timely study start-up or the effective and efficient progression of the study
Assists with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of a study
Under close supervision, interfaces with potential study subjects for the purpose of promoting participation in research studies
Assists with the screening of subjects for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol and under the direction of the PI
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 in accordance with timelines established by the study sponsor
Processes and ships study specific lab specimens as directed by the PI
Performs study specific procedures at protocol directed intervals under the supervision of the PI
Provides general support for research projects as directed by the PI, Director, or other site personnel
Obtains and updates essential documents for specific studies, as necessary
Attends clinical research-related training as required
Assists with study close-out activities as directed by PI
Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
Escalates issues to supervisor for resolution, as deemed necessary
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
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
Strong communication skills, verbal and written
Strong organizational skills
Ability to take direction
Certified Medical Assistant preferred
Nice to have
Certified Medical Assistant preferred
0-1 year experience in a medical setting and/or clinical research preferred