CCRA - Certified Clinical Research Associate

CCRA Course Description:

Certified Clinical Research Associate is a Certification offered by the Academy called Association of Clinical Research Professionals. It is necessary to certify eligible candidates for the knowledge and experience they possess in certain areas. Appropriate practical knowledge alongside classroom training enables a candidate to be well aware of Clinical Research. Further, based on the candidate's interest in the domain, makes him/her a step eligible to be certified professional.

Prerequisites to take up Certification (CCRA):

• A Bachelor's degree from a recognized university (or)
• Associate's Degree [LPN, LVN, RN] (or)
• High School Diploma
• Experience as Medical Assistant / Lab Technician
• Pre-eligibility test

   Candidates interested in taking up the Certification exam are directed to attend a pre-eligibility exam intended to check the eligibility of the person in pursuing the certification. In this exam, the Association of Clinical Research Professionals determine the eligibility of the participant.

 Target Audience for CCRA:

• Graduates
  
• Students with experience as Lab Technician / Medical Assistant
  

 CCRA Course Details and Exam Syllabus:

• Scientific Concepts and Research Design
  
• Ethical and Participant Safety Considerations
  
• Product Development and Regulations
  
• Clinical Trial Operations (GCPs)
  
• Study and Site Management
  
• Data Management and Informatics
  

 Content for Certified Clinical Research Associate Training and Certification Exam.

1. Scientific Concepts and Research

1.1: Components of Product Development

1.2: Protocol Elements

1.3: Investigational Brochure Elements

1.4: Rational Elements subjected to Eligibility requirements

1.5: Rationale for complying with Protocol

1.6: Design Characteristics

1.7: Objective Study

1.8: Design Study

1.9: Assignments, Randomization, Open Label, Registries

 2. Ethical and Participant Safety Considerations

2.1: Event Classification, Documentation and Reporting

2.2: Components specifying Subject Eligibility requirements

2.3: Confidentiality and Privacy requirements

2.4: IB Elements

2.5: Informed Consent Form

2.6: Informed Consent Element

2.7: Human Subjects Protection

2.8: Violation of Protocol

2.9: Recruitment Strategies

2.10: Safety Monitoring

2.11: Strategies of Subject Retention

2.12: Safety of Subject Issues

2.13: Vulnerable Subject Populations

2.14: Clinical Research Conflict of Interest

 3. Product Development and Regulation

3.1: Audit and Inspection Process

3.2: Clinical Development Process

3.3: Fraudulent Elements and Misconception

3.4: IRB Reporting Requirements

3.5: IEC Reporting Requirements

3.6: Product Development Lifecycle

3.7: Protocol Amendment and Approval Process

3.8: Regulatory Reporting

3.9: Safety Reporting

 4. Clinical Trial Operations (GCPs)

4.1: Delegation of responsibilities

4.2: Elements of Effective corrective and Preventive action

4.3: Elements of rationale (Plan Monitoring)

4.4: Investigator's brochure elements

4.5: Monitoring Activities

4.6: Pre-study/Site Selection visit activities

4.7: Responsibilities of Principle Investigator

4.8: Risk Based Monitoring

4.9: Project Feasibility Considerations

4.10: Roles of Clinical Trial entities

4.11: Site Close-Out Activities

4.12: Site Initiation Activities

4.13: Site Selection Criteria

4.14: Staff Oversight

4.15: Qualification of Staffs

4.16: Training requirements of Staff

4.17: Close-out activity study

 5. Study and Site Management

5.1: Requirements of Communication documentation

5.2: Corrective and Preventive actions

5.3: Equipment/ Supply and Maintenance

5.4: Investigational Product Accountability and Documentation requirements

5.5: Investigational Product characteristics

5.6: Investigational Product labelling

5.7: Investigational Product packaging

5.8: Investigational Product reference

5.9: Investigational Product Shipment

5.10: Investigational Product Storage

5.11: Non-Compliance Management

5.12: Project Timeline

5.13: Purpose of Protocol Compliance

5.14: Processes of Protocol Compliance

5.15: Roles of Clinical Trials

5.16: Subject Compliance Assessment

5.17: Subject Responsibilities for Study Participation

5.18: Subject Visit Activities

 6. Data Management and Informatics

6.1: Activities comprising Data Management

6.2: Principles of Data Privacy

6.3: Elements of Data Collection Tools

6.4: Elements and Process of Data Query

6.5: Pharmacovigilance Elements

6.6: Documents essential for Conducting Clinical Trial

6.7: Retention Record

6.8: Source Data Review

6.9: Source Data Verification

6.10: Source Documentation

6.11: Documentation Study of Practices

 CCRA Exam Blueprint:

The Certification exam for Clinical Research Associate consists of 125 Multiple Choice questions. Out of these 125 questions, 25 are pre-test items. The exam duration will be 3 Hours. All multiple choice questions are served with 4 options out which candidates are required to choose the best answer among them. 

 Results and Notification:

Results of Candidates will be e-mailed or Postal mailed to their respective addresses. However the candidates who have attended the Certification exams will also receive an official notification of Certification status from the Academy (Association of Clinical Research Professional).

 How to become a Clinical Research Associate?

To become a qualified Clinical Research Associate, a participant should have successfully crossed all the below steps:

 Step-1: Ensure the chosen Clinical Research path is the right one for you.

 Step-2: You should have pursued a graduate degree in Nursing, Medical Sciences or Life Sciences.

 Step-3: If you aren't holding a Graduate Degree in any of the above areas, an associate degree in LPN, LVN or RN would do the job.

 Step-4: If you have experience as a Lab Technician or a Medical Assistant you are certainly qualified to attend the certification program.

 Step 5: You are eligible to take up the certification program on matching any of the above qualifications.

 Step 6: The next step is to enroll in a CRA course and to attend a preliminary test developed by the Academy (Association of Clinical Research Professional).

 Step-7: On clearing the preliminary test, the candidate could get enrolled in the certification training without further assessments.

 Step-8: The training program constitutes of current Industry Syllabus which is provided in detail while learning.

 Step-9: The Candidates will be scheduled an Examination date on which they are allotted to appear for the Certification Exam.

 Step-10: On clearing the Certification exam, you are certified a Clinical Research Associate Professional.

 Step-11: The Candidate will also get the Certification from the Academy through e-mail or by post.

 Certified Clinical Research Professional Salary and Jobs:

Usually a Certified Clinical Research Professional is paid an average salary of $ 77,700 USD. Some of the top tier companies hiring Clinical Research Professional include Mount Sinai Health Systems, NYU Langone Medical Center, Columbia University, Rutgers University etc., According to a recent survey, there are over 400+ Entry Level, 300+ Middle level and about 100 Senior level experienced slots available to be filled by eligible candidates in New York, NY. Some of the designations include Clinical Research Associate, Clinical Research Associate 1, Clinical Research Associate 2, Clinical Research Associate 3, Clinical Research Coordinator, Research Technician, Clinical Research Scientist, etc.,

 Certification Training Fee:

Member:

Application Fee           - $ 135 USD

Exam Fee                    - $ 325 USD

Total                             - $ 460 USD

 Non Member:

Application Fee           - $ 200 USD

Exam Fee                   - $ 400 USD

Total                            - $ 600 USD

 Certification Training Mode:

Classroom Training

Online Training - Tutor Based

Online Training - Self paced learning