Clinical Trials & Regulatory Affairs Intern – CRO

About the Company

ICON plc is a global Contract Research Organization (CRO) dedicated to advancing clinical research and development. We partner with pharmaceutical, biotechnology, and medical device companies worldwide to accelerate the development of new drugs and therapies. With a commitment to innovation and quality, ICON helps bring life-changing medicines to patients faster. Our diverse team of experts works across various therapeutic areas, providing comprehensive clinical development services from early phase to post-market surveillance.

Job Description

We are seeking a highly motivated and detail-oriented Clinical Trials & Regulatory Affairs Intern to join our dynamic team in Carrickfergus. This internship offers an invaluable opportunity to gain hands-on experience within a leading global Contract Research Organization (CRO). You will work closely with experienced professionals, supporting critical functions in clinical trial operations and regulatory submissions. This role is designed for individuals eager to learn about the complexities of drug development, regulatory compliance, and the essential role of a CRO in bringing new therapies to market. The position will involve a hybrid work model, combining on-site presence for training and collaboration with some flexibility for remote work.

Key Responsibilities

  • Assist in the preparation and review of clinical trial documentation, including protocols, informed consent forms, and study reports.
  • Support regulatory submissions by compiling and organizing essential documents for ethics committee and regulatory authority review.
  • Participate in the maintenance of trial master files (TMF) and investigator site files (ISF), ensuring accuracy and compliance with GxP guidelines.
  • Conduct literature searches and research on specific therapeutic areas, regulatory guidelines, and industry best practices.
  • Support data entry and quality control activities related to clinical trial management systems.
  • Assist in the coordination of meetings, preparation of agendas, and distribution of meeting minutes.
  • Learn about regulatory requirements specific to clinical trials in different regions.
  • Contribute to ongoing projects by providing administrative and logistical support to the clinical operations and regulatory affairs teams.

Required Skills

  • Currently enrolled in or recently graduated from a Bachelor's or Master's degree program in Life Sciences, Pharmacy, Biomedical Science, or a related field.
  • Strong academic record.
  • Excellent written and verbal communication skills.
  • High level of attention to detail and organizational abilities.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Ability to work effectively both independently and as part of a team.
  • Demonstrated eagerness to learn and proactive attitude.

Preferred Qualifications

  • Basic understanding of clinical research principles (e.g., ICH-GCP).
  • Familiarity with regulatory frameworks (e.g., FDA, EMA) for drug development.
  • Previous exposure to a laboratory or research environment.
  • Experience with medical terminology.

Perks & Benefits

  • Structured mentorship program with experienced industry professionals.
  • Exposure to real-world clinical trials and regulatory processes.
  • Opportunity to contribute to impactful projects in drug development.
  • Networking opportunities within a global CRO.
  • Professional development workshops and training.
  • Hybrid work model offering flexibility.
  • Competitive intern stipend.

How to Apply

If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:

  • An up-to-date Resume or CV
  • A brief cover letter summarizing your experience and motivation

Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.

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