Understanding the Role of a Crc:

• Managing the conduct of the clinical trial, recruit and interact with patients.

• Ensuring compliance with the study protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements.

• Organizing the study team, collecting and managing data accurately, schedule visits and follow-up.

• Work closely with investigators to ensure study success and patient safety.

• Report results to regulatory authorities and sponsors.

Guides and Checklists:

• Essential Documents Checklist:
  A comprehensive checklist of all the essential documents required to start a clinical trial, including:

  • Patient Recruitment and Enrollment Checklist

  • Regulatory Documentation and Compliance Guide

  • Data Collection and Entry Standards

  • Visit and Follow-up Protocols

  • Adverse Event (AE) Reporting and Management

  • Delegation of Duties Log

  • End of Study Closeout Checklist

    • Remember, the FDA requires complete study documents to be kept by sponsors and sites for a minimum of two years. Some IRBs and Institutions may have different internal requirements.

• Regulatory Compliance Guide:
  A guide to understanding and adhering to key regulations in clinical research, such as:

  • Good Clinical Practice (GCP) guidelines

  • International Council for Harmonisation (ICH) guidelines

  • U.S. Food and Drug Administration (FDA) regulations

  • Institutional Review Board (IRB) processes

• Patient Recruitment Tips:
  Effective strategies for recruiting and retaining study participants:

  • Building and maintaining strong relationships with local healthcare providers.

  • Ensuring diversity and inclusion in participant recruitment.

Networking and Development:

• Professional Organizations:

  Joining professional organizations can greatly enhance your career as a PI:

  • Association of Clinical Research Professionals (ACRP): Offers certifications, networking opportunities, and educational resources.

  • Drug Information Association (DIA): Provides a platform for professionals to share insights and stay updated on industry trends.

  • Society of Clinical Research Associates (SOCRA): Focuses on professional development and certification for clinical research professionals.

• Upcoming Conferences:

  Stay informed about upcoming conferences and events that are pivotal for career growth:

  • ACRP Annual Meeting: A major event for clinical research professionals with workshops, networking, and educational sessions.

  • DIA Global Annual Meeting: Covers global perspectives on clinical research, with opportunities to meet industry leaders.

  • Clinical Trials on Alzheimer’s Disease (CTAD): Focused on clinical research in neurodegenerative diseases, offering specialized knowledge in this field.

Career Advancement Tools:

• Free Webinars:
  Access a library of free webinars covering topics such as:

  • Best practices in clinical trial management.

  • Updates on regulatory changes.

  • Advances in patient recruitment strategies.

  • Ethical considerations in research.

• Certification Programs:
  Enhance your credentials with industry-recognized certifications:

  • Certified Clinical Research Coordinator (CCRC): A certification demonstrating your competence in managing clinical trials.

  • Good Clinical Practice (GCP) Certification: Essential for anyone involved in clinical research, this certification ensures you are up-to-date with international research standards.