About The Position
The Clinical Research Assistant coordinates research projects conducted at St. Vincent Medical Center and throughout Bon Secours Mercy Health 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 is expected to maintain current knowledge of applicable federal regulations, guidelines, and developments in research. The position involves coordinating regulatory documentation, supporting Institutional Review Board submissions, assisting with grant and budget applications, and communicating with study participants, investigators, hospital personnel, sponsors, vendors, research sites, and regulatory bodies. It also includes research data management, specimen handling, financial reporting, and contributing to audits, educational programs, abstracts, manuscripts, and conference presentations. The employee must provide care appropriate to the age and developmental needs of patients served by the assigned unit, following departmental policies and procedures. This is a collective bargaining unit position. Mercy Health describes its benefits as varying by market and employment status.
Requirements
- Ability to write, follow, and monitor study protocols; recruit and assist with consenting study subjects; collect and enter data; and follow institutional policies, federal 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 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 age-appropriate patient care and understand life-span growth and development.
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, and monitor compliance with protocols, institutional policies, federal regulations, and ICH/GCP guidelines.
- Assist with preparing Institutional Review Board documents, including informed consent documents, initial applications, adverse event reports, protocol revisions, and annual and final project reports.
- Assist with preparing grant and study budget applications.
- Recruit and screen eligible study subjects through physician and interdisciplinary referrals and electronic databases; inform relevant personnel about project and subject status.
- Advise investigators and other relevant individuals on regulatory issues.
- Serve as a liaison among subjects, investigators, departments, research sites, sponsors, vendors, and regulatory committees and agencies.
- Assist with and participate in sponsor quality assurance audits and FDA compliance audits, as required.
- Help prepare charts, graphs, and other illustrations to support interpretation of research findings.
- Assist with clinical research and investigational drug therapy education for nursing and other appropriate personnel.
- Help prepare research abstracts and manuscripts, posters, and presentation slides, and represent Mercy Health at research-related local, regional, and national meetings.
- Manage research data, including database preparation, data entry, and generating and resolving queries; 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 institutional policies, federal regulations, and IC/GCP guidelines as they apply to research.
- Collaborate with associates, researchers, and physicians to develop and implement joint research studies throughout Mercy Health.
- Organize and prioritize multiple research projects, work independently and in teams, and maintain confidentiality of information and records.
- Prepare monthly billing and financial reports as needed and assist with recording deposits and financial allocations for accounting purposes.
- Coordinate, obtain, process, store, and/or ship protocol-required laboratory samples, which may include blood, serum, plasma, urine, sputum, and tissue.
- Demonstrate knowledge and skills for providing care appropriate to patients' ages and developmental needs, in accordance 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
