About: The Certified Clinical Research Professional (CCRP®) credential, offered by the Society of Clinical Research Associates (SOCRA), is an esteemed certification for healthcare professionals involved in clinical research. This certification recognizes individuals who demonstrate proficiency in managing clinical trials and ensures they meet the rigorous standards required for success in the field. Clinical Research Professionals (CRPs) play pivotal roles in research settings, including academic institutions, pharmaceutical companies, Site Management Organizations (SMOs), and Clinical Research Organizations (CROs).
Certification Body: Society of Clinical Research Associates (SOCRA).
Learning Objective: The CCRP® certification validates an individual’s ability to:
- Coordinate research study protocols and ensure regulatory compliance.
- Manage and monitor clinical trials from start to closure.
- Handle research study products, train staff, and maintain study records.
- Execute research studies while ensuring patient safety, data integrity, and adherence to ethical standards.
Exam Information:
- Exam Format: Written exam.
- Total Exam Duration: 4 hours.
- Total Number of Questions: 107 questions.
- Scored Questions: 97 questions.
- Pre-Test Questions: 10 questions (not scored).
- Exam Domains:
- Domain 1: Research Study Start-Up.
- Domain 2: Research Study Implementation.
- Domain 3: Research Study Closure.
Recertification:
- Renewal Period: Every three years
- Requirement: Completion of continuing education
- Purpose: Demonstration of ongoing professional competence
- Process: Submit a recertification application to maintain the credential
For More Information
Curriculum
- 3 Sections
- 18 Lessons
- 40 Hours
- Domain 1: Research Study Start-Up7
- 1.1Oversee the development and initiation of the research study protocol.
- 1.2Prepare or acquire all necessary study documentation.
- 1.3Secure approvals from relevant stakeholders for the study.
- 1.4Procure study-related materials, equipment, tools, and aids.
- 1.5Identify and select appropriate research study sites.
- 1.6Conduct training sessions for research staff members.
- 1.7Assess and ensure compliance with research protocols and guidelines.
- Domain 2: Research Study Implementation7
- 2.1Carry out the execution of the research study in accordance with the protocol.
- 2.2Ensure adherence to all regulatory and compliance standards.
- 2.3Manage and oversee the use of research study products.
- 2.4Identify, document, and address any anomalies or deviations in the study.
- 2.5Supervise the management of research subjects.
- 2.6Maintain the integrity of the research study through continuous monitoring.
- 2.7Facilitate effective communication with all stakeholders involved in the study.
- Domain 3: Research Study Closure4
- 3.1Conduct the study closeout visit in alignment with study requirements.
- 3.2Perform audits to ensure the research study’s accuracy and compliance.
- 3.3Prepare and submit comprehensive closure reports for the research study.
- 3.4Archive and manage retrieval of all research study records for future reference.
Requirements
- Option 1: A minimum of two years of full-time experience as a Clinical Research Professional in the last five years.
- Option 2: A degree in Clinical Research with one year of full-time experience in the last two years.
- Option 3: A Bachelor’s or Master’s Degree in Clinical Research with a minimum of 12 credit hours and at least one year of full-time experience in the past two years.
Target audiences
- Nursing professionals
- Pharmacy professionals
- Biology specialists
- Health sciences practitioners
- Medical technologists
- Business administration professionals