CLINICAL RESEARCH COORDINATOR - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
6 Weeks / 47 Days
 
 

Clinical Research Coordinator

Introduction – Clinical Research Coordinator

Qtech-Sol specializes in Clinical Science Training, offering a comprehensive program geared towards individuals aspiring to work as Clinical Research Coordinators (CRC). Our course is meticulously structured to provide a strong foundation and practical skills necessary for these job roles.

The program places a strong emphasis on the pivotal role of CRC in various aspects of clinical research, including protocol design, site initiation, trial conduct, ongoing monitoring, and effective management of clinical trial data capture and audits. Our curriculum is strategically crafted to provide students with a competitive advantage in securing employment opportunities as CRCs within the pharmaceutical, biotechnology, medical device, clinical research organizations (CROs), and research clinic sectors.

Course Name :  Clinical Research Coordinator
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  CRCT
Course Material : This course contains and delivers 30 Lessons.
Every lesson encompasses diverse delivery methods, including
  1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
  2. Course Reading Material: Comprehensive chapters designed to facilitate an in-depth understanding of the subject matter.
  3. Practice Quizzes: A set of 15 quizzes to reinforce learning and assess your progress.
  4. Assessment Tests: Ten different test sets to evaluate your grasp of the material.
  5. Short Questions: Succinct questions to encourage critical thinking and quick recall.
  6. Role-Based Tasks: Practical exercises tailored to specific roles, accompanied by detailed solutions for comprehensive learning.
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

CRCT-SIP Delivery – 6 Weeks / 47 Days (Self-Paced)

Introduction

A Clinical Research Coordinator (CRC) plays a pivotal role in the management of clinical trials and studies associated with pharmaceutical and biotechnological products, medications, and medical procedures. Their responsibilities encompass a wide range of tasks, including:

  1. Participant Recruitment: Identifying and enrolling suitable study participants.
  2. Data Collection: Gathering and recording patient data in a meticulous manner.
  3. Study Documentation: Crafting and maintaining essential study documents.
  4. Quality Assurance Audits: Conducting thorough assessments to ensure adherence to study protocols and quality standards
  5. Report Compilation:Compiling and finalizing reports derived from extensive, long-term clinical trials.

In addition to these core functions, CRAs serve as a vital link between the study’s sponsor, often a pharmaceutical company or contract research organization (CRO), and the clinical sites where the research is conducted. This intermediary role is crucial in maintaining the transparency and integrity of clinical trial results, ensuring that they remain free from any undue influence or bias associated with the sponsor’s interests.

To excel in this role, a successful CRA must possess exceptional attention to detail, a high level of education, and the ability to communicate effectively with both sponsor representatives and clinical personnel. Their dedication to upholding the highest standards of research ethics and protocol adherence is paramount to the successful execution of clinical trials.

Course Enrollment process

Qtech-Sol offers a flexible approach to learning through our self-paced online courses. Students have the freedom to commence their studies at their convenience, following a straightforward process.

  1. Member Registration: Begin by registering as a member of our platform
  2. Course Selection: Explore and choose the course that best suits your needs and goals.
  3. Enrollment and Tuition: Complete the enrollment process and make the necessary tuition payment.
  4. Access Learning Materials: Access course materials and resources through our Learning Management System (LMS).
  5. Support and Assistance:Receive support and assistance via email or schedule Google Meet sessions through the LMS.
  6. Course Task Submissions:Submit course-related tasks and assignments as per the provided schedule.
  7. Final Examination:Upon finishing the course, take the final examination to demonstrate your understanding.
  8. Course Completion:Upon successful completion, receive a course completion certificate and a transcript.
  9. Post-Training Support:Take advantage of our post-training support for assistance with resume building, narrative development, and mock interviews.

This step-by-step process ensures a smooth and flexible learning experience, allowing you to acquire valuable skills and knowledge at your own pace.

Building Relevant Experience

The Clinical Research Coordinator (CRC) plays a pivotal role in the conduct of clinical research, whether it’s at research hospitals or within Clinical Research Organizations (CROs). The CRC’s primary responsibility is to manage the daily operations of clinical studies and trials, ensuring that they are conducted in compliance with the study protocol, regulatory requirements, and ethical standards. Here’s a breakdown of their key roles and responsibilities:

  • Study Planning and Preparation: CRCs assist in the planning and design of clinical studies, including the development of study protocols and case report forms (CRFs). They ensure that all necessary approvals are obtained from institutional review boards (IRBs) or ethics committees before the study begins.
  • Participant Recruitment and Consent: CRCs play a crucial role in recruiting participants for clinical trials, which involves screening potential participants to ensure they meet the study criteria. They also obtain informed consent, ensuring that participants are fully aware of the study’s nature, procedures, risks, and benefits.
  • Data Collection and Management: They are responsible for collecting, managing, and maintaining accurate, complete, and timely data. This involves overseeing the administration of study treatments, monitoring participants for adverse events, and ensuring that all data is correctly recorded in CRFs or electronic data capture systems.
  • Compliance and Quality Control: Ensuring compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements is a critical role of the CRC. They conduct regular monitoring and auditing of study activities to ensure data integrity and compliance.
  • Communication and Coordination: CRCs serve as the primary point of contact for all study stakeholders, including investigators, sponsors, and participants. They facilitate effective communication between all parties involved in the research and coordinate various study-related activities.
  • Reporting: They are responsible for preparing and submitting reports to stakeholders, which may include progress reports, safety reports, and final study reports. This also involves reporting adverse events or deviations from the study protocol to regulatory authorities and sponsors.
  • Training and Supervision: In many cases, CRCs are also involved in training and supervising other study staff members to ensure that everyone is aware of their roles and responsibilities and is competent to perform their assigned tasks.

At research hospitals, CRCs may work more closely with academic researchers and healthcare providers, focusing on studies that advance medical knowledge and patient care. In contrast, within CROs, CRCs might work on a broader range of studies, often for pharmaceutical or biotech companies, focusing on the development and approval of new drugs or medical devices.

Upon successful completion of our program, individuals can explore various job titles, including but not limited to:

  1. Clinical Study Coordinator
  2. Research Nurse
  3. Clinical Trial Manager
  4. Study Site Coordinator
  5. Clinical Project Coordinator
  6. Clinical Data Coordinator
  7. Patient Recruitment Coordinator
  8. Clinical Research Nurse Coordinator
  9. Clinical Research Project Coordinator

This comprehensive training equips aspiring professionals with the skills and knowledge needed to thrive in the dynamic field of clinical research.

Educational Requirements:

Preferred Qualifications: A candidate with an associate or bachelor’s degree in life sciences or a related health field is highly recommended for admission into this course. Some of the eligible majors for enrollment include Medicine, Nursing, Pharmacy, Public Health, Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical Engineering, Pharmacology, Toxicology, and Healthcare Administration.

Support After Training:

Your resume is often the first impression you make on recruiters and potential employers. In today’s competitive job market, it’s crucial to ensure that your resume meets industry standards and effectively represents your qualifications. That’s where our Post-Training Assistance (PTA) program comes in.

Our PTA program offers valuable assistance in resume building, interview preparation, and mock interviews. It’s not just about creating a strong resume; it’s also about understanding the current job market in your area, identifying available positions, gauging salary ranges, and ensuring that your resume aligns with your career goals. During the PTA program, you’ll have the opportunity to engage with our course specialists, taking small but meaningful steps toward your professional success. We’ll work together as a team to help you achieve your career objectives.

   Key Learning Outcomes and Benefits for Students:

  1. Enhancing the knowledge and skills required for your field.
  2. Improving your resume to increase your chances of landing promising job opportunities.
  3. High-value learning at an affordable cost.
  4. Flexibility to learn from anywhere, at your own pace.
  5. Practical tasks aligned with real-world industry practices and job roles.
  6. Application of concepts in real-time scenarios, including policies, governance, and industry tools.
  7. Engaging in role-based tasks commonly practiced in the industry.
  8. Preparation with mock interviews and interview narratives for effective client discussions.
  9. Readiness to work with minimal support, boosting your confidence in your chosen field.
Professional Organizations and Associations:

Consider joining professional organizations and associations related to your field. These groups offer valuable networking opportunities, resources, and insights from fellow professionals. They can help you stay updated on industry trends and discover new career prospects.

Stay Informed:

Explore global clinical resource information to stay informed about the latest news and updates in areas like clinical trials, regulatory matters, clinical data management (CDM), and pharmacovigilance.

Overview of the Curriculum

Our program has been meticulously crafted by industry experts to provide students and young professionals with the essential knowledge and skills needed to pursue careers in the field. It offers a comprehensive understanding of the roles and responsibilities associated with Clinical Research Coordinators (CRCs). The curriculum encompasses both theoretical and practical aspects of these roles, equipping students with the necessary expertise and exposure to meet industry standards.

Clinical Research Coordinator Curriculum
1. Introduction to Clinical Research Coordination

2. Introduction To Clinical Trial

3. Phase I Clinical Trials

4. Phase II Clinical Trials

5. Phase III Clinical Trials

6. Phase IV Clinical Trials

9. Regulatory and Ethical Framework in Clinical Research

10. Study Startup and Site Preparation

11. Clinical Trial Budget

12. Site Initiation

13. Ethical Considerations and Patient Advocacy

14. Patient Management in Clinical Trials

15. Data Management and Documentation

16. Source Documentation, Retention and Compliance

17. Clinical Trial Monitoring and Site Visits

18. Safety Reporting and Pharmacovigilance

19. Support to the Principal Investigator

20. Investigator-Monitor Meetings

21. Quality Assurance and Audit Preparedness

22. Safety Reporting and Pharmacovigilance

23. Introduction to Adverse Event Reporting and Classification

24. Drug Accountability Plan

25. Professional Development in Clinical Research

26. Project Management and Communication Skills

27. Introduction to Adverse Event Reporting and Classification

28. Site Monitoring

29. Investigator-Monitor Meetings

30. Trial Master File (TMF)

31. Clinical Trial on Site Audit

32. Site Close-Out

Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.