Investigator Research Assistant – Neuro – St. Vincent Medical Center

Mercy Health•Toledo, OH

22h•Hybrid

About The Position

Responsible for assisting in all aspects of Investigator Initiated Studies coordinated through the central coordinating center. This role involves acting as a safety medical monitor, facilitating communication between various teams and vendors, reconciling subcontracts, assisting with site initiation visits, and contributing to the drafting and submission of study abstracts, presentations, and manuscripts. The position also includes clinical administrative operations activities such as contract and budget support, filing, scanning, and quality control of documentation.

Requirements

Minimum one year of experience in clinical research.
Minimum one year of experience in writing.
Minimum one year of experience in drafting clinical papers.
Minimum one year of experience in abstract submission to scientific meetings.
Minimum one year of experience in submission of full clinical research papers to journals.
Base statistical knowledge and analysis performance.
Relevant experience typically includes document management and systems experience in other CMS tools including Excel and TMF.
Ability to work with financial analyst and manager to ensure the QC of the budgets and accounts.

Nice To Haves

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

Responsibilities

Act as a safety medical monitor by reviewing and documenting clinical events and serious clinical events, providing monthly reports to the research team.
Facilitate communication with the central statistical center, Data Safety Management Team, study sites, third-party vendors, core imaging center, and subcontractors.
Reconcile and assist in obtaining and completing subcontracts from national research sites.
Assist with site initiation visits, including preparing presentation slides.
Perform remote and occasional on-site monitoring that requires travel to sites.
Assist in drafting and proofreading study abstracts and meeting presentations.
Submit abstracts to meeting websites.
Help in drafting and preparing papers/manuscripts.
Perform double-checking and statistical analysis as needed.
Submit full papers to journals.
Assist with clinical administrative operations activities, including clinical contract and budget support.
File documentation from all sites in accordance with regulatory and compliance rules (FDA, study regulations).
Perform Quality Control (QC) on scanned contracts to ensure completeness, presence of signatures, legibility of budget pages, and proper saving in the Shared Folder.
Assist with maintaining administration of invoices from other sites with the help of the CCC team.
Work with the financial analyst and manager to ensure QC of budgets and accounts.