Clinical Research & Regulatory Affairs Co - op

Ideal for students interested in biotech, medicine, research, or graduate school pathways.

Cleveland, Ohio (On-site) | Full-Time (40 hrs/week)

About NovelMed Therapeutics

NovelMed Therapeutics is a clinical-stage biotechnology company developing next-generation monoclonal antibody therapies targeting the complement system for rare and serious diseases. Our work focuses on translating cutting-edge science into clinical-stage therapeutics and FDA-ready programs, offering a unique opportunity to experience the full drug development lifecycle.

Position Overview

We are seeking highly motivated BS/MS/PhD students (CPT/OPT eligible) for a 6–12-month full-time co-op supporting clinical research and regulatory affairs activities across active drug development programs. This role provides hands-on exposure to clinical trials, FDA submissions, and regulatory documentation, with direct involvement in ongoing clinical-stage work. This role is particularly well-suited for students seeking hands-on industry experience within a clinical-stage biotechnology environment.

Key Responsibilities

• Support preparation of clinical protocols, amendments, and study reports
• Assist in FDA regulatory submissions and IND-related documentation
• Analyze and organize clinical data, tables, figures, and summaries
• Maintain document formatting, version control, and regulatory compliance
• Assist with clinical trial operations, site coordination, and study materials
• Contribute to SOP development and documentation control processes
• Collaborate with clinical, regulatory, and scientific teams

Qualifications

• BS/MS/PhD student in Biomedical Engineering, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field
• Eligible for CPT/OPT/Co-op
• Strong attention to detail and organizational skills
• Effective written and verbal communication skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Interest in clinical research, immunology, drug development, or regulatory affairs
• Wet lab or research experience preferred but not required

What You Will Gain

• Hands-on experience in clinical-stage drug development
• Direct exposure to FDA regulatory processes and submissions
• Experience working on Phase II/III clinical programs
• Training in clinical documentation, data analysis, and compliance
• Mentorship from experienced scientific and regulatory professionals

Location

11000 Cedar Avenue, Cleveland, Ohio 44106, Across from Case Western Reserve University with convenient housing and transportation options.

How to Apply

Send your Resume, Cover Letter, and Transcript(s) to: ***email_hidden*** & [email protected]

Subject Line: Clinical Research & Regulatory Affairs Co-op Application