Investigator Research Assistant - St. Vincent Medical Center - PRN
Mercy Health BSMH•Toledo, OH
About The Position
The Investigator Research Assistant assists in all aspects of Investigator Initiated Studies coordinated through the central coordinating center. The role supports study safety monitoring, coordination among research sites and vendors, site initiation and monitoring, research publications and presentations, and clinical administrative operations, including contract, budget, documentation, and invoice support. Duties may include other job-related tasks as required 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
- When needed, act as a safety medical monitor by reviewing and documenting the review of clinical events and serious clinical events recorded by sites, and provide a monthly report to the Central Coordinating Center (CCC) research team.
- Facilitate communication among the central statistical center, Data Safety Management Team, study sites reporting to the CCC, electronic data vendor, subcontractors, and core imaging center, and 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, including preparing slides about the study and its requirements, and conduct remote and occasional on-site monitoring that requires travel to sites.
- Assist with drafting and proofreading study abstracts and meeting presentations, submitting abstracts to meeting websites, preparing papers and manuscripts, performing or double-checking statistical analyses as needed, and submitting completed papers to journals.
- Support clinical administrative operations involving clinical contracts and budgets, including filing, scanning, mailing, populating spreadsheets, and other administrative tasks.
- File documentation received from sites and maintain it according to 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 and work with the financial analyst and manager to ensure 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.
