Clinical Research Coordinator I - Frenova

Fresenius Medical Care•Mishawaka, IN

12d

About The Position

PURPOSE AND SCOPE: Supports Frenova Renal Research by providing 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. PRINCIPAL DUTIES AND 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

Requirements

High School Diploma required; Associate’s Degree or Certified Medical Assistant preferred.
2-4 years of experience of related experience preferred.
Minimum 18 months experience in a medical setting and/or clinical research setting required
Willingness to obtain research specific training as needed.
Ability to meet deadlines for multiple concurrent projects.
Ability to understand and follow study specific protocol and direction.
Ability to understand a patient medical record.
Attention to detail required
Good computer skills including MS Excel.
Strong communication skills, verbal and written.
Strong organizational skills.
Ability to take direction.

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