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Clinical Research Associate

Clinical Research Associate

Overview

Clinical Research Associates (CRAs) play a pivotal role in the medical and pharmaceutical industries. Their primary responsibility is to ensure that clinical trials are conducted ethically, safely, and in accordance with regulatory standards. CRAs act as liaisons between research sponsors, investigators, and regulatory authorities, facilitating the smooth progress of clinical studies from initiation to completion. Here are several reasons highlighting the importance of CRAs: They Ensure Regulatory Compliance, Maintain Data Integrity, Manage Site Relationships, Conduct Site Visits and Monitor, Facilitate Communication, Support Study Documentation and Reporting and Contribute to Scientific Advancement.

Who can do this course?

Anyone who has a Bachelor level degree or advanced degree in a scientific or healthcare-related stream. Such as Biology, chemistry, Biochemistry, pharmacology, Nursing, Health/Biomedical sciences, Pharmacy and clinical research. Some positions may necessitate additional certifications in clinical research.

Curriculum
  • Introduction to Clinical trials and regulatory standards
  • Clinical Trail Designs: Designing and conducting clinical trials
  • Data entry in EDC and source data verification.
  • Monitoring Visits: The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, & the applicable regulatory requirements.
  • Patient recruitment and retention process.
  • Informed consent process.
  • eTMF: Background, scope current products available for a successful conduct of clinical trials.
  • Investigational Product: Role of a CRA in the process of receipt, storage and handling of the IP at site.
  • Electronic Data Capture (EDC) Systems: Dive deeper into EDC systems, focusing on advanced functionalities, system validation, user management, and troubleshooting. Explore different EDC platforms commonly used in clinical research.
  • Data Quality Assurance and Quality Control: Learn advanced techniques for ensuring data quality throughout the clinical trial process. This includes developing comprehensive data validation plans, performing risk-based monitoring, and implementing quality control measures.
  • Data Privacy and Security: Deepen understanding of data privacy laws and regulations, including HIPAA and GDPR. Learn best practices for safeguarding patient data and ensuring compliance with privacy regulations.
  • Clinical Trial Data Reporting: Gain expertise in generating and submitting clinical trial data for regulatory submissions, including INDs, NDAs, and marketing authorization applications. Understand the requirements for data formatting, documentation, and submission timelines.
  • Protocol Adherence and Compliance: Proven ability to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines across all study sites. Experience in identifying and resolving protocol deviations and implementing corrective actions as needed.
  • Site Selection and Management: Learn how to effectively select and manage clinical trial sites, including site feasibility assessments, site initiation visits, and ongoing site monitoring activities.
  • Project Management in Clinical Data Management: Develop project management skills specific to clinical data management, including resource allocation, timeline management, risk assessment, and communication with stakeholders.
  • Monitoring and Data Quality Oversight: Strong proficiency in conducting on-site monitoring visits, including pre-study, initiation, interim, and close-out visits. Experience in reviewing source documents, verifying data accuracy, and ensuring data integrity throughout the trial.
  • Safety Reporting and Pharmacovigilance: Gain knowledge of adverse event reporting requirements, safety monitoring processes, and pharmacovigilance practices in clinical research. Understand the importance of patient safety and risk management.
  • Essential Documents: Documents to be submitted at end of the trial for regulatory approval.
Features
Real Life Case Studies

Real Life Case Studies

Projects modeled on select use cases with implementation of diverse technology concepts

Assignments

Assignments

All guided classes and courses are mandatorily followed by useful practical assignments

24x7 Expert Support

24x7 Expert Support

Every technical query is resolved on demand with readily available expert assistance

Instructor-led Sessions

Instructor-led Sessions

Technical session conducted under the guidance of qualified and certified educationists

Course structure

Daily hours of training

2 hours per day

Duration of training

3-4 weeks

Material

Well prepared material which includes PPTs and PDFs and Database documents will be provided.

Resume Preparation

Resume preparation will be done once the candidate completes the training

Placement

Based on your training performance, we will help you to find a Job.

Course Info

Course Start Date 05/07/2024
Estimated Duration 3/4 Weeks
Maximum Students 10
Levels Advanced

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