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.
Summary of Primary Function/General Purpose of Position
Coordinates research projects conducted at Mercy Health Cardiology. 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 Job Functions
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 insure 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. These specimens include but are not limited to blood, serum, plasma, urine, sputum and/or tissue.
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. Collects pertinent data and notifies the physician investigator and/or other appropriate personnel of any significant findings.
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 at St. Vincent Mercy Medical Center and throughout Bon Secours Mercy Health.
Collaborates and fosters relationships with other St. Vincent Mercy Medical Center and/or Bon Secours Mercy Health researchers, and physicians to develop, acquire, and implement joint research studies to be conducted at the Medical Center and throughout Bon Secours Mercy Health.
Demonstrates behaviors consistent with Mission and Core Values (Compassion, Excellence, Human Dignity, Justice, Sacredness of Life, Service) of Bon Secours Mercy Health.
Adheres to the standards and policies of the Corporate Responsibility Program, including the duty to comply with applicable laws and regulations, and reporting to designated Manager (or employer hotline) any suspected unethical, fraudulent, or unlawful acts or practices.
Embraces Standards of Behavior in order to provide and promote excellent customer service for both internal and external customers. Holds self and others accountable for behaviors that promote service excellence.
Adheres to all standards and policies regarding safety/patient safety initiatives.
Is responsible for all other duties as assigned.
This document is not an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. Employees may be required to perform other job related duties as required by their supervisor, subject to reasonable accommodation.
Education Qualifications
Required Minimum Education:
2 Year/ Associates Degree
Specialty/Major: Nursing (Bachelor's or Master's preferred)
Licensure/Certification Required: Must possess a current license as a Registered Nurse from the state of Ohio. Certification in clinical research required or must obtain within one year of eligibility.
Minimum Years and Type of Experience: 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.
Other Knowledge, Skills and Abilities Required: 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 Harmonization 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 Bon Secours Mercy Health 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.).
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.).
* Individuals in this position are required to exercise universal precautions, use personal protective equipment and devices, and learn the policies concerning infection control.
Many of our opportunities reward* your hard work with:
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
And much more
*Benefits offerings vary according to employment status
All applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health - Youngstown, Ohio or Bon Secours - Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employers, please email recruitment@mercy.com . If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com
