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Regulatory Research Summer 2025 Intern

0-2 years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Research Summer 2025 Intern

Location: Cincinnati, Ohio
Department: Site Activation & Maintenance
Job ID: 11168

Job Summary:
Our clinical operations activities are growing rapidly, and we’re currently seeking several full- or part-time, office-based interns to support our Regulatory Submissions team within the Site Activation and Maintenance (SAM) Department during the Summer 2025 semester. This group plays a key role in the study start-up/site activation process at Medpace by communicating with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins screening patients for clinical trials. The Regulatory Submissions Intern will provide support to the Regulatory Submissions Coordinators and Managers as they maintain start-up timelines, review and collect regulatory documents, and proactively identify solutions to regulatory issues.

Responsibilities:

  • Provide support to the study start-up team through compliance tasks;
  • Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
  • Gain hands-on training and exposure to the clinical trial start-up phase through our Site Activation & Maintenance (SAM) Training Program.

Site Activation & Maintenance (SAM) Training Program:
Medpace training programs are curated to educate and support experienced associates, as well as those new to the industry. The SAM Training Program embraces evidence-based learning & development models to advance professional learning and employee performance. In the program, you will:

  • Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;
  • Gain exposure to real-world tasks through a robust mentoring program; and
  • Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.

Qualifications:

  • High school diploma, pursuing a bachelor's degree in business or life sciences preferred;
  • Excellent organizational and prioritization skills;
  • Knowledge of Microsoft Office;
  • Availability to work a minimum of 20 hours per week in our Cincinnati, OH office (full-time preferred).

Travel: None

Medpace Overview:
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 5,000 people across 40+ countries.

Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks:

  • Flexible work environment;
  • Competitive PTO packages, starting at 20+ days;
  • Competitive compensation and benefits package;
  • Company-sponsored employee appreciation events;
  • Employee health and wellness initiatives;
  • Community involvement with local nonprofit organizations;
  • Discounts on local sports games, fitness gyms, and attractions;
  • Modern, eco-friendly campus with an on-site fitness center;
  • Structured career paths with opportunities for professional growth;
  • Discounted tuition for UC online programs.

Awards:

  • Named a Top Workplace in 2024 by The Cincinnati Enquirer;
  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024;
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

What to Expect Next:
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for the next steps.

EO/AA Employer: M/F/Disability/Vets