Investigator Research Assistant - St. Vincent Medical Center

About the role

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

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 the central statistical center, Data Safety Management Team, study sites reporting to the CCC, third‑party vendor providing electronic data to the CCC and to all sites, any needed third‑party subcontract to maintain services across all sites and with the third‑party vendor, core imaging center, and assuring timely completion of tasks.
• Reconcile and assist the manager in obtaining and completing subcontracts from all national research sites.
• Assist in site initiation visits with slides to illustrate the study and requirements; perform remote and occasional on‑site monitoring that requires travel to the sites.
• Assist in drafting and proof‑editing study abstracts, meeting presentations, submission of abstracts to meeting websites, help drafting of papers/manuscripts, double‑checking and performing statistical analysis as needed, and submission of full papers to journals.
• Assist with clinical administrative operations involving clinical contract and budget support, including filing, scanning, mailing, populating spreadsheets, and other administrative tasks as assigned.
• File documentation obtained from all sites and maintain it in accordance with regulatory and compliance rules per FDA and study regulations.
• Perform Quality Control (QC) on scanned contracts to ensure: all pages are included; all required signatures are verified and present; all budget pages are legible; and all documents are saved in the Shared Folder for the CCC team.
• Assist with maintaining administration using CCC team invoices from other sites; work with the financial analyst and manager to ensure QC of budgets and accounts.

Qualifications

• Bachelor's Degree in healthcare, research, or a related field (required).
• 1 year experience in clinical research, writing, drafting clinical papers, abstract submission to scientific meetings, submission of full clinical research papers to journals, and basic statistical knowledge and analysis (required).

Skills

• Document management
• Microsoft Office
• Demonstrated knowledge of technology and its application to improving processes
• Demonstrated management skills or experience
• Ability to work independently with minimal supervision
• Ability to work effectively as a team member

Benefits

• 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