Clinical Research Nurse (RN) - St Vincent Medical Center

Toledo, OH

Hospitals

About the position

At Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence. The position coordinates research projects conducted at MSVMC and throughout BSMH facilities, with primary responsibilities including recruiting and monitoring study participants, maintaining research materials, ensuring protocol compliance, and assisting research investigators in developing and completing research projects. The role requires maintaining current knowledge of federal regulations, guidelines, and developments in the field of research.

Responsibilities

• Works with investigators and personnel to develop research protocols.
• 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 subjects who meet the protocol requirements through networking with primary physician and other interdisciplinary personnel.
• Works with research subjects and/or their legally authorized representative to explain projects and ensure informed consent.
• Coordinates clinical and pharmacokinetic research studies, protocol interventions with nurses, physicians, pharmacists and other ancillary personnel, in compliance with the study protocol.
• May perform study procedures where qualified and needed.
• Collects observational data (i.e., medical record, surveys, interviews, etc.).
• Dispenses and/or administers investigational medication, as required.
• Coordinates, obtains, processes, stores, and/or ships laboratory samples for analysis, as required by the protocol.
• Manages data, including database preparation, data entry, and query generation and resolution.
• Maintains detailed, complete and accurate research files.
• Acts as a liaison between subjects, investigators, other departments, other research sites, sponsors, vendors, and regulatory committees and agencies.
• Informs physicians, nurses, manager, and other pertinent personnel of status of projects, subjects, etc.
• Monitors compliance with the protocol, institutional policies, federal regulations and Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).
• Monitors all research subjects closely and observes for patient response to therapy and any adverse experiences.
• Conducts literature reviews through the Internet and/or library.
• Assists with discharge planning for research subjects.
• Maintains pager for taking call, as needed, 24 hours per day.
• Assists with the preparation for 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 the preparation of research abstracts and manuscripts for publication, posters, and slides for presentation at a conference.
• Advises investigators and other pertinent individuals on relevant regulatory issues.
• Maintains a working knowledge and understanding of institutional policies, federal regulations and ICH/GCP guidelines as they pertain to research.
• Plans, develops and presents education programs on clinical research and investigational drug therapy to nursing and other appropriate personnel.
• Represents St. Vincent Mercy Medical Center and Bon Secours Mercy Health at local, regional, and national meetings in conjunction with research studies being conducted.
• Collaborates and fosters relationships with other researchers and physicians to develop, acquire, and implement joint research studies.

Requirements

• Associates Degree of Nursing.
• Bachelor's or Master's of Nursing Degree preferred.
• Prior clinical research experience and understanding of the scientific process preferred.
• Minimum of 3-5 years of recent clinical experience required.
• Critical care experience desirable.
• Ability to write, follow and monitor study protocols, recruit and consent study subjects, collect and enter data, and follow institutional policies, U.S. Food and Drug Administration (FDA) regulations and International Conference on Harmonisation Good Clinical Practice guidelines.
• Must possess analytical skills necessary to retrieve data accurately from the medical record, evaluate significance, and present data as necessary.
• Excellent written and oral communication skills to write and edit clear precise and grammatically correct correspondences, scientific abstracts, manuscripts, and presentations.
• Must possess excellent interpersonal skills sufficient to develop and maintain cooperative working relationships with physicians, nurses, other researchers, sponsors, research subjects and families, regulatory officials, and a variety of other personnel.
• Ability to work independently and in a team-oriented environment, follow through on assignments with minimal direction, and to 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.
• Must possess computer skills necessary to work with a variety of software (i.e., Windows, Microsoft Office, Word, Excel, Access, Power Point, Outlook, Internet, Epic, etc.).

Benefits

• Comprehensive, affordable medical, dental and vision plans.
• Prescription drug coverage.
• Flexible spending accounts.
• Life insurance w/AD&D.
• Employer contributions to retirement savings plan when eligible.
• Paid time off.
• Educational Assistance.