Clinical Research Assistant - Clinical Research Toledo Other Research - St. Vincent Medical Center

Mercy Health BSMH • Toledo, OH

4d

About The Position

The Clinical Research Assistant coordinates research projects conducted at MHSVMC and throughout BSMH facilities. The role supports research investigators by recruiting and monitoring study participants, maintaining project materials, ensuring protocol compliance, and assisting with the development and completion of research projects. The assistant maintains current knowledge of federal regulations, guidelines, and developments in research.

The position involves coordinating regulatory records and Institutional Review Board submissions, helping prepare grant and study budget applications, recruiting and screening participants, managing research data and files, and serving as a liaison among participants, investigators, clinical departments, research sites, sponsors, vendors, and regulatory bodies. The assistant may perform study procedures when qualified, trained, and needed, and may process and ship laboratory specimens according to study protocols.

The role also supports audits, research education, publications and conference presentations, financial reporting, and collaboration on research studies across Mercy Health. It requires interpersonal skills, independent and team-based work, organization, confidentiality, and the ability to prioritize and complete multiple projects. The employee must provide care appropriate to the age and developmental needs of patients served, consistent with departmental policies and procedures.

Requirements

• Ability to write, follow, and monitor study protocols; recruit and assist with consenting study subjects; collect and enter data; and follow institutional policies, FDA regulations, and ICH/CGP guidelines.
• Excellent written and oral communication skills, including the ability to write and edit clear, precise, grammatically correct correspondence, scientific abstracts, manuscripts, and presentations.
• Computer skills sufficient to work with a variety of software.
• Ability to develop and maintain cooperative working relationships with physicians, nurses, researchers, sponsors, participants and families, regulatory officials, and other personnel.
• Ability to work independently and in a team-oriented environment, follow through with minimal direction, and prioritize work independently.
• Ability to maintain confidentiality with tact and discretion.
• Knowledge and skills necessary to provide care appropriate to the ages of patients served, including understanding lifespan growth and development and assessing information relevant to patient needs.

Nice To Haves

• Prior clinical research experience and understanding of the scientific process.
• Associate degree in science or another applicable major.
• Bachelor’s degree in science or another applicable major.

Responsibilities

• Work with investigators and personnel to implement research protocols and coordinate regulatory documents and files in compliance with study protocols.
• Monitor compliance with protocols, institutional policies, federal regulations, and ICH/GCP guidelines.
• Assist in preparing Institutional Review Board documents, including informed consent documents, initial applications, adverse event reports, protocol revisions, annual reports, and final reports.
• Assist with preparing grant and study budget applications.
• Recruit and screen eligible research participants through physician and interdisciplinary networks and electronic databases.
• Inform physicians, nurses, managers, and other relevant personnel about project and participant status; advise relevant individuals on regulatory issues.
• Serve as a liaison among participants, investigators, departments, research sites, sponsors, vendors, and regulatory committees and agencies.
• Assist with preparation for and participation in sponsor quality assurance and FDA compliance audits.
• Prepare charts, graphs, and other illustrations to help interpret research findings.
• Assist with clinical research and investigational drug therapy education for nursing and other appropriate personnel.
• Assist with research abstracts and manuscripts, and prepare posters and slides for conference presentations.
• Represent Mercy Health at local, regional, and national meetings related to hospital research studies.
• Manage research data, including database preparation, data entry, and query generation and resolution; maintain detailed and accurate research files.
• Collect observational data from medical records, surveys, interviews, and other sources.
• Perform study procedures when qualified, trained, and needed; conduct literature reviews using the Internet or library resources.
• Maintain knowledge of institutional policies, federal regulations, and IC/GCP guidelines relevant to research.
• Collaborate across departments with associates, researchers, and physicians to develop, obtain, and implement joint research studies.
• Organize, coordinate, and complete multiple research projects while maintaining confidentiality of information and records.
• Prepare monthly billing and financial reports as needed, and assist with recording deposits and financial allocations for accounting.
• Coordinate, obtain, process, store, and/or ship laboratory samples as required by protocols.
• Demonstrate knowledge and skills to provide age-appropriate care and apply knowledge of lifespan growth and development to patient needs.

Benefits

• Competitive pay, incentives, referral bonuses, and 403(b) with employer contributions when eligible.
• Medical, dental, vision, and prescription coverage; HSA/FSA options; life insurance; mental health resources; and discounts.
• Paid time off, parental and FMLA leave, short- and long-term disability, and backup care for children and elders.
• Tuition assistance, professional development, and continuing education support.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed