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

THIS IS A COLLECTIVE BARGAINING UNIT POSITION

Summary of Primary Function/General Purpose of Position

Coordinates research projects conducted at the MHSVMC and throughout BSMH facilities. 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 Functions

- Works with investigators and personnel to implement research protocols. Coordinates regulatory documents and files in compliance with the study protocol. Monitors compliance with the protocol, institutional policies, federal regulations and ICH/GCP guidelines.
- 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 and screens subjects who meet the protocol requirements through networking with primary physician and other interdisciplinary personnel and using electronic databases. Informs physicians, nurses, managers, and other pertinent personnel of status of projects, subjects, etc. Advises investigators and other pertinent individuals on relevant regulatory issues.
- Acts as a liaison between subjects, investigators, other departments, other research sites, sponsors, vendors, and regulatory committees and agencies to communicate needs of the research department or regulatory bodies.
- Assists with the preparation 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 education programs on clinical research and investigational drug therapy to nursing and other appropriate personnel. Assist with the preparation of research abstracts and manuscripts for publication, posters and slides for presentation at a conference. Represents Mercy Health at local, regional and national meetings in conjunction with research studies being conducted at the Hospital.
- Manages data, including database preparation, data entry, and query generation and resolution. Maintains detailed, complete and accurate research files. Collects observational data (i.e., medical record, surveys, interviews, etc.). May perform study procedures where qualified, trained and needed. Conducts literature reviews through the Internet and/or library.
- Maintains a working knowledge and understanding of institutional policies, federal regulations and IC/GCP guidelines as they pertain to research.
- Collaborates and fosters interdepartmental relationships with other associates, researchers, and physicians to develop, acquire and implement joint research studies to be conducted throughout Mercy Health. Must possess excellent interpersonal skills sufficient to develop and maintain cooperative working relationships with physicians, nurses, other researchers, sponsors, research participants and families, regulatory officials, and a variety of other Mercy personnel.
- Ability to work independently and in a team-oriented environment, follow through on assignments with minimal direction, and 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.
- Prepares monthly billing and financial reports as needed. Assists with recording deposits and financial allocation for accounting purposes.
- 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.
- 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.
- Demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit.
- Demonstrates knowledge of the principles of growth and development of the life span and possesses the ability to assess data reflective of the patient's status and interprets the appropriate information needed to identify each patient's requirements relative to his or her age, specific needs and to provide the care needed as described in departmental policies and procedures.

Education Qualifications

Preferred Education:

- 2 Year/ Associates Degree
- Specialty/Major: Science or other applicable major
- 4 year/ Bachelors Degree
- Specialty/Major: Science or other applicable major

Minimum Qualifications

Minimum Years and Type of Experience:

- Prior clinical research experience and understanding of the scientific process preferred.

Other Knowledge, Skills and Abilities Required:

- Ability to write, follow and monitor study protocols, recruit and  assist with consenting of study subjects, collect and enter data and follow institutional policies, federal (FDA) regulations and ICH/CGP guidelines. Excellent written and oral communication skills to write and edit clear precise and grammatically correct correspondences, scientific abstracts, manuscripts, and presentations. Must possess computer skills necessary to work with a variety of software.

As a Mercy Health associate, you're part of a Mission that matters. We support your well-being—personally and professionally. Our benefits are built to grow with you and meet your unique needs, every step of the way.

What we offer

- Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)

- Medical, dental, vision, prescription coverage, HSA/FSA options, life insurance, mental health resources and discounts

- Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders

- Tuition assistance, professional development and continuing education support

Benefits may vary based on the market and 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 [email protected] . 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 [email protected]