Thank you for considering a career at Mercy Health!
Scheduled Weekly Hours:
36
Work Shift:
Days (United States of America)
THIS IS A COLLECTIVE BARGAINING UNIT POSITION
Summary of Primary Function/General Purpose of Position
Coordinates research projects conducted at the MHSVMC and throughout BSMH facilities. Primary responsibilities include recruiting and monitoring study participants, maintaining research materials required for coordinating projects, protocol compliance, assisting research investigators in developing and completing research projects. Required to maintain current knowledge of federal regulations, guidelines and developments in the field of research.
Essential Functions
Works with investigators and personnel to implement research protocols. Coordinates regulatory documents and files in compliance with the study protocol. Monitors compliance with the protocol, institutional policies, federal regulations and ICH/GCP guidelines.
Assists with the preparation of written documents for the Institutional Review Board, such as informed consent documents, initial project applications, adverse event reports, protocol revisions, annual project reports, and final project reports.
Assists with preparation of grant and study budget applications.
Recruits and screens subjects who meet the protocol requirements through networking with primary physician and other interdisciplinary personnel and using electronic databases. Informs physicians, nurses, managers, and other pertinent personnel of status of projects, subjects, etc. Advises investigators and other pertinent individuals on relevant regulatory issues.
Acts as a liaison between subjects, investigators, other departments, other research sites, sponsors, vendors, and regulatory committees and agencies to communicate needs of the research department or regulatory bodies.
Assists with the preparation and participates in sponsor-related quality assurance audits and FDA compliance audits, as required. Assists with the preparation of charts, graphs, and other illustrations, to facilitate interpretation of research findings.
Assists with education programs on clinical research and investigational drug therapy to nursing and other appropriate personnel. Assist with the preparation of research abstracts and manuscripts for publication, posters and slides for presentation at a conference. Represents Mercy Health at local, regional and national meetings in conjunction with research studies being conducted at the Hospital.
Manages data, including database preparation, data entry, and query generation and resolution. Maintains detailed, complete and accurate research files. Collects observational data (i.e., medical record, surveys, interviews, etc.). May perform study procedures where qualified, trained and needed. Conducts literature reviews through the Internet and/or library.
Maintains a working knowledge and understanding of institutional policies, federal regulations and IC/GCP guidelines as they pertain to research.
Collaborates and fosters interdepartmental relationships with other associates, researchers, and physicians to develop, acquire and implement joint research studies to be conducted throughout Mercy Health. Must possess excellent interpersonal skills sufficient to develop and maintain cooperative working relationships with physicians, nurses, other researchers, sponsors, research participants and families, regulatory officials, and a variety of other Mercy personnel.
Ability to work independently and in a team-oriented environment, follow through on assignments with minimal direction, and independently prioritize work. Initiative, creativity, tenacity and patience to effectively organize, develop, coordinate and complete multiple research projects on time. Ability to maintain confidentiality of information and records with tact and discretion.
Prepares monthly billing and financial reports as needed. Assists with recording deposits and financial allocation for…