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.
Other duties as assigned