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Clinical Research Assistant Lead
1 month ago
Job Summary
The Senior Clinical Research Assistant serves as a lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Department of Psychiatry and Behavioral Health. This role is responsible for supervising the overall recruitment process to maximize efficiency and provide an excellent participant experience.
Key Responsibilities
- Identify, recruit, interview, and promote study to eligible participants
- Educate participants and families on the purpose, goals, and processes of clinical studies
- Lead patient enrollment activities and ensure informed consent authorization is obtained and administered in compliance with regulatory and sponsor requirements
- Facilitate collection, processing, and evaluation of biological samples, biometric testing, and overall biomarker sample and data collection for assigned projects
- Supervise, implement, and coordinate the conduct of daily activities of research studies, including scheduling and follow-through of study visits, procedures, and other testing
- Monitor participants for adverse reactions to study treatment, procedure, or medication and notify appropriate clinical professionals to evaluate patient response, identify status of complications, and provide appropriate level of care
- Document unfavorable responses and notify research sponsors and applicable regulatory agencies
- Participate in collecting, extracting, coding, and analyzing clinical research data
- Assist with activities to ensure compliance with Institutional Review Boards (IRB), FDA, federal, state, and industry sponsor regulations
- Participate in planning, organizing, and preparing for external compliance and quality assurance and control reviews
- Actively participate in internal quality assurance audits
- Participate in the development of new research protocols and contribute to planning goals to meet study requirements
- Assist with the preparation and submission of publications, research reports, and grant proposals
Requirements
- Bachelor's Degree in biological sciences, health sciences, or a medical field or an equivalent combination of education and experience
- Two years of experience in a clinical research capacity conducting clinical research studies
- Experience or knowledge in psychiatry/behavioral health preferred
- Computer skills required with experience using Microsoft Software applications desired
Travel Requirements
This position requires more than 50% travel within the state of Ohio.