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

Bon Secours Mercy Health • Toledo, OH

2d

About The Position

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

The position works with investigators and other personnel to implement research protocols; prepares regulatory and Institutional Review Board documentation; supports recruitment, screening, data collection, and study procedures when qualified, trained, and needed; and serves as a liaison among participants, investigators, departments, research sites, sponsors, vendors, and regulatory bodies. It also contributes to audits, research education, publications and presentations, financial reporting, and the handling of laboratory samples as required by study protocols.

The role requires strong interpersonal and communication skills, the ability to work independently and collaboratively, and the ability to organize and complete multiple projects while maintaining confidentiality. The employee must demonstrate knowledge and skills appropriate to the ages and developmental needs of patients served.

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/GCP 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.
• Excellent interpersonal skills to develop and maintain cooperative working relationships with physicians, nurses, researchers, sponsors, research 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.
• Initiative, creativity, tenacity, and patience to organize, develop, coordinate, and complete multiple research projects on time.
• Ability to maintain confidentiality with tact and discretion.
• Knowledge and skills necessary to provide care appropriate to the ages of patients served, including understanding life-span growth and development and assessing patient needs.
• Preferred education: an associate degree in science or another applicable major, or a bachelor's degree in science or another applicable major.

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.
• 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, project applications, adverse event reports, protocol revisions, and periodic and final reports.
• Assist with preparation of grant and study budget applications.
• Recruit and screen eligible subjects through physician and interdisciplinary networks and electronic databases.
• Inform physicians, nurses, managers, and other relevant personnel about project and subject status.
• Advise investigators and relevant personnel on regulatory issues.
• Act as a liaison among research subjects, 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.
• Assist in preparing charts, graphs, and other illustrations of research findings.
• Assist with clinical research and investigational drug therapy education programs for nursing and other personnel.
• Assist in preparing research abstracts and manuscripts and presentation materials such as posters and slides.
• 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 complete 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 and/or library resources.
• Maintain working knowledge of applicable institutional policies, federal regulations, and ICH/GCP guidelines.
• Collaborate with associates, researchers, and physicians to develop and implement joint research studies throughout Mercy Health.
• Prepare monthly billing and financial reports as needed.
• Assist with recording deposits and financial allocations for accounting purposes.
• Coordinate, obtain, process, store, and/or ship laboratory samples for analysis as required by the protocol.
• Provide care appropriate to the ages and developmental needs of patients served, consistent with departmental policies and procedures.

Benefits

• Competitive pay, incentives, referral bonuses, and a 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: Associate degree