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Fresenius Medical Care · 2 days ago

Sr. Clinical Research Assistant

Jersey City, NJ

Full-time

Onsite

Mid, Senior Level

$24/hr - $36/hr

1+ years exp

Fresenius Medical Care is a healthcare company focused on renal research, and they are seeking a Senior Clinical Research Assistant to provide administrative and clinical support for clinical trials. The role involves ensuring regulatory compliance, assisting with study procedures, and maintaining communication with various stakeholders throughout the research process.

BiotechnologyHealth CareMedical Device

Responsibilities

Utilizes experience and knowledge to act as a resource and provide on-going leadership and support to Clinical Research Assistant I, answering questions and providing assistance as needed

Conducts on the job training for Clinical Research Assistant I as requested

Researches and identifies research related issues and discrepancies when evident and appropriately escalates to site manager, Director, and/or principal investigator for resolution as needed

Obtains and prepares 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

Ensures documents and forms are compiled and submitted in a timely manner to Frenova Renal Research, 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

Interfaces with potential study subjects for the purpose of promoting participation in research studies

Assists with screening 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

Responsible for 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

Assist with various projects as assigned by direct supervisor

Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations

Other duties as assigned

Qualification

Clinical research experienceRegulatory document preparationClinical Practice (GCP)Data entry skillsMS Excel proficiencyBilingual English/SpanishTake directionCommunication skillsOrganizational skillsAttention to detail