Investigator Research Assistant – Neuro – St. Vincent Medical Center

Bon Secours Mercy Health • Toledo, OH

12d • 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 teams and sites, reconciling subcontracts, assisting with site initiation visits, and contributing to the drafting and submission of research documents like abstracts and manuscripts. The position also includes clinical administrative operations, contract and budget support, filing, scanning, and quality control of documentation.

Requirements

• 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

Responsibilities

• 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.
• 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.

Benefits

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
• Medical, dental, vision, prescription coverage, HAS/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

What This Job Offers

• Career Level: Entry Level