Clinical Research Internship Program (120 hours)
This
comprehensive clinical research internship program offers interns a
unique opportunity to gain hands-on experience and develop a deep
understanding of various aspects of the clinical trial process. Over the
course of 120 hours, interns will explore the following key areas:
- Confidentiality Agreement: At the outset of the internship, interns will learn about the critical importance of maintaining confidentiality in clinical research. They will review and sign a confidentiality agreement that outlines their legal and ethical responsibilities in protecting sensitive information, such as patient data, study protocols, and other confidential materials related to the research study.
- Investigator's Brochure for Clinical Trials: Interns will delve into the Investigator's Brochure (IB), a comprehensive document that provides detailed information about the investigational product being studied. They will review the non-clinical and clinical data, potential risks and benefits, and other critical details that help investigators understand the product and assess the risks to study participants.
- Maintenance of the Study Site Master File: Interns will learn the proper procedures for maintaining the study site master file, which serves as the central repository for all essential documents related to the clinical trial. This includes organizing and filing regulatory documents, study protocols, case report forms, and other critical records to ensure the trial is conducted in compliance with regulations.
- Drawing Blood and Tissue Sampling: Interns will receive hands-on training in the proper techniques for drawing blood and collecting tissue samples from study participants. They will learn to follow safety protocols and accurately document the sample collection process, which is a crucial aspect of clinical trials.
- Measuring Vital Signs in Clinical Trials: Interns will learn how to accurately measure and record vital signs, such as blood pressure, heart rate, respiratory rate, and temperature, for study participants. This skill is essential for monitoring the safety and health of participants throughout the clinical trial.
- Establishing the Process for Reading and Implementing a Clinical Research Protocol: Interns will thoroughly study a clinical research protocol, understanding the study objectives, eligibility criteria, study procedures, and other key elements. They will then learn how to effectively implement the protocol at the study site, ensuring adherence to the research plan.
- Implementing the Informed Consent Process for Clinical Trials: Interns will observe and participate in the informed consent process, where study participants are provided with detailed information about the trial and their rights. They will learn how to effectively communicate the informed consent form, address participant questions, and document the consent process.
- Managing Source Documentation in Clinical Research: Interns will gain experience in managing source documentation, which includes all original records related to clinical trial participants, such as medical charts, laboratory results, and case report forms. They will learn the importance of maintaining accurate and complete source documentation to ensure data integrity and regulatory compliance.