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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

Responsible for assisting in all aspects of Investigator Initiated Studies coordinated through the central coordinating center.

Essential Functions

+ Act as a safety medical monitor when needed by reviewing and documenting the completion of the reviews of all clinical events and all serious clinical events recorded by the sites and provide a monthly report to the Central Coordinating Center (CCC) research team

+ Assist in facilitating communication with central statistical center, Data Safety Management Team, the study sites that are reporting to the CCC at St. Vincent, third party vendor providing the electronic data to the CCC and to all sites, any needed third party subcontract to maintain services needed across all sites and with the third party vendor, core imaging center and assuring timely completion of the tasks

+ Reconcile and assist the manager in obtaining and completing the subcontracts from all the national research sites

+ Assist in site initiation visits with slides to illustrate the study and requirements, Remote and occasional on site monitoring that requires travel to the sites

+ Assist in Drafting and proof editing study abstract, meeting presentations, Submission of abstract to meeting website, Help and drafting of the paper/manuscript preparation, Double checking and performing statistical analysis as needed, submission of full paper to the journals

+ Responsible for assisting with the clinical administrative operations activities involving clinical contract and budget support including but not limited to filing, scanning, mailing, populating spreadsheets and other administrative tasks as assigned. Duties and functions include:

+ Filing the documentation obtained from all sites and maintaining it in accordance with regulatory and compliance rules as per FDA, and study regulations.

+ Perform Quality Control (QC) on the scanned contracts to ensure: All pages of the documents are included; all required signatures are verified and present; all budget pages are legible; and all documents have been saved in the Shared Folder for CCC team.

+ Assist with maintaining administration with the help of CCC team invoices from other sites. Work with financial analyst and manager to ensure the QC of the budgets and accounts.

Required Minimum Education:

4 year/ Bachelors Degree

Specialty/Major:

Healthcare, research or related field

Preferred Education:

4 year/ Bachelors Degree

Specialty/Major:

Healthcare, research or related field

Minimum Qualifications

Minimum Years and Type of Experience:

1 year

Other Knowledge, Skills and Abilities** **Required:

Minimum one year of experience in clinical research, writing, drafting clinical paper, abstract submission to scientific meetings, submission of full clinical research paper to journal, base stat knowledge and analysis performance

Other Knowledge, Skills and Abilities** **Preferred:

Relevant experience typically includes document management and systems experience in other CMS tools including Excel and TMF

Combination of post-secondary education and experience in lieu of a degree

_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._

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 [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]