Investigator Research Assistant – Orthopedic – St. Vincent Medical Center

Mercy Health•Toledo, OH

21h•Onsite

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 research entities, assisting with site initiation and monitoring, drafting and proofreading study-related documents, and performing administrative tasks related to clinical contracts and budgets. The position requires meticulous attention to detail in filing, scanning, and quality control of documents to ensure compliance with regulatory and study requirements.

Requirements

Minimum one year of experience in clinical research.
Minimum one year of experience in writing and 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.
Four year/Bachelors Degree in Healthcare, research or related field.
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.

Nice To Haves

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.
Four year/Bachelors Degree in Healthcare, research or related field.

Responsibilities

Act as a safety medical monitor by reviewing and documenting clinical events and serious clinical events, and provide monthly reports to the research team.
Facilitate communication with the central statistical center, Data Safety Management Team, study sites, third-party vendors, and core imaging centers to ensure timely task completion.
Reconcile and assist in obtaining subcontracts from national research sites.
Assist with site initiation visits, including preparing presentation materials.
Perform remote and occasional on-site monitoring, which may require travel.
Assist in drafting and proofreading study abstracts and meeting presentations, and submit abstracts to meeting websites.
Help draft and prepare papers/manuscripts for publication.
Perform double-checking and statistical analysis as needed.
Assist with clinical administrative operations, including contract and budget support (filing, scanning, mailing, populating spreadsheets).
File and maintain documentation from all sites in accordance with regulatory and compliance rules (FDA, study regulations).
Perform Quality Control (QC) on scanned contracts to ensure completeness, proper signatures, legibility of budget pages, and correct 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.