Investigator Research Assistant PRN - St. Vincent Medical Center

Mercy Health BSMH • Toledo, OH

3d

About The Position

The Investigator Research Assistant is responsible for assisting in all aspects of Investigator Initiated Studies coordinated through the central coordinating center. The role supports clinical study safety monitoring, communications among research teams and vendors, site initiation and monitoring, study publications and presentations, and clinical administrative operations, including contract, budget, invoice, and document support.

The position also supports regulatory-compliant filing and quality control of scanned contracts and study documents, and works with the CCC team, financial analyst, and manager to maintain accurate budgets and accounts. Other job-related duties may be assigned by the supervisor, subject to reasonable accommodation.

Requirements

• Bachelor's degree in healthcare, research, or a related field.
• At least 1 year of experience in clinical research.
• Experience writing or drafting clinical papers, submitting abstracts to scientific meetings, and submitting full clinical research papers to journals.
• Basic statistical knowledge and analysis skills.
• Document management skills.
• Microsoft Office skills.
• 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.

Responsibilities

• Act as a safety medical monitor when needed by reviewing and documenting reviews of clinical events and serious clinical events recorded by study sites, and provide monthly reports to the Central Coordinating Center research team.
• Facilitate communication among the central statistical center, Data Safety Management Team, study sites reporting to the CCC, third-party data vendors and subcontractors, and the core imaging center; help ensure timely completion of tasks.
• Reconcile and assist the manager in obtaining and completing subcontracts from national research sites.
• Assist with site initiation visits by preparing slides that illustrate the study and its requirements.
• Conduct remote and occasional on-site monitoring, including travel to research sites.
• Assist with drafting and proof-editing study abstracts and meeting presentations, submitting abstracts to meeting websites, drafting papers and manuscripts, checking and performing statistical analyses as needed, and submitting full papers to journals.
• Assist with clinical administrative operations involving clinical contracts and budget support, including filing, scanning, mailing, populating spreadsheets, and other administrative tasks.
• File documentation obtained from sites and maintain it in accordance with FDA, regulatory, compliance, and study requirements.
• Perform quality control on scanned contracts to verify that all pages are included, required signatures are present, budget pages are legible, and documents are saved in the CCC team's shared folder.
• Assist the CCC team with administration of invoices from other sites.
• Work with the financial analyst and manager to perform quality control of budgets and accounts.

Benefits

• Competitive pay, incentives, referral bonuses, and a 403(b) with employer contributions when eligible.
• Medical, dental, vision, and prescription coverage; HSA/FSA options; life insurance; mental health resources; and discounts.
• Paid time off, parental and FMLA leave, short- and long-term disability, and backup care for children and elders.
• Tuition assistance, professional development, and continuing education support.
• Benefits may vary based on the market and employment status.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level