Investigator Research Assistant PRN - St. Vincent Medical Center

Mercy Health • Toledo, OH

11d

About The Position

The Investigator Research Assistant assists with all aspects of investigator-initiated studies coordinated through the central coordinating center (CCC). The role supports study safety monitoring, communication and coordination among research sites and vendors, site initiation and monitoring, research writing and statistical analysis, and clinical administrative operations involving contracts, budgets, documentation, and invoices.

The position also supports compliance with FDA and study regulations by maintaining site documentation and performing quality control on scanned contracts and related records. Additional 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, writing and drafting clinical papers, submitting abstracts to scientific meetings, submitting full clinical research papers to journals, and basic statistical knowledge and analysis.
• Knowledge of document management.
• Proficiency with 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.

Responsibilities

• Act as a safety medical monitor when needed by reviewing and documenting reviews of clinical events and serious clinical events reported by study sites, and provide monthly reports to the CCC research team.
• Facilitate communication among the central statistical center, Data Safety Management Team, study sites, third-party vendors, subcontractors, and core imaging center, while helping 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 illustrating the study and its requirements; conduct remote and occasional onsite monitoring, including travel to sites.
• Assist in drafting and proofreading study abstracts and meeting presentations, submitting abstracts to meeting websites, drafting research papers and manuscripts, performing or double-checking statistical analysis as needed, and submitting completed papers to journals.
• Support clinical administrative operations involving clinical contracts and budgets, including filing, scanning, mailing, spreadsheet population, and other assigned administrative tasks.
• File documentation from all sites and maintain it in accordance with FDA, regulatory, compliance, and study requirements.
• Perform quality control on scanned contracts to confirm all pages are included, required signatures are present, budget pages are legible, and documents are saved in the CCC shared folder.
• Help maintain administration of invoices from other sites with the CCC team and work with the financial analyst and manager to quality-check 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.

What This Job Offers

• Career Level: Entry Level