CRC 250IN - Clinical Research Site Coordination and Management

1. Coordinate and manage an identified clinical research project from study start-up to study close-out.
2. Explain the elements of the study budget as it relates to the execution of a protocol.
3. Prepare a recruitment plan to recruit and retain study subjects
4. Develop a management plan for the research site project
5. Collect and record data into an electronic data capture system

1. Coordinating an Identified Clinical Research Project
   1. Development of an overall plan for a specified clinical research project
   2. Elements of Project Management
   3. Developing a detailed plan (including time lines) for each phase of the clinical research project
   4. Effective communication needed between project team members and clinical trial management
   5. Decision-making process for accepting and conducting a research project
   6. Importance, design, and use of set timelines in a research project
   7. Study goals and deadlines for clinical research trials
   8. Operational Site Management
   9. Drafting Standard Operating Procedures
   10. Implementing Corrective and Preventive Action Plans
   11. Quality Audits
   12. Quality Controls
   13. Mitigating problems that can commonly occur between clinical research sites and Sponsors/Contract Research Organizations
2. Planning and Preparation of Research Budgets and Contracts
   1. Process involved in the development of a research study budget
   2. Routine calculations associated with the costs of a clinical research trial
   3. Analysis of budget components for a specified clinical trial relative to cost effectiveness
   4. Assisting in the calculations of an overall research project budget, including personnel costs, overhead, and profit margin
   5. Funding sources for clinical research project
   6. Role and responsibility of a clinical research investigator and coordinator in the development of a research contract
3. Application of Regulatory, Legal, and Governing Parameters with a Clinical Research Project
   1. Function, activities, and responsibilities of an Institutional Review Board (IRB)
   2. Requirements for membership on an IRB according to the Code of Federal Regulations, Title 21 (21 CFR 56.107)
   3. Maintaining and retaining of IRB records
   4. IRB submission process and the standard review criteria used by an IRB
   5. “Expedited review criteria”
   6. Communication responsibilities between the investigator and the IRB
   7. Eight basic elements of an informed consent form according to Good Clinical Practice (GCP) and Federal regulations and development of a sample consent form
   8. Study file record retention and requirements
   9. Contractual relationships in a clinical research project or study
   10. Study document checklist
   11. How to complete a form FDA-1572
   12. Elements needed in a current curriculum vitae
   13. Regulatory documents needed prior to shipping investigational supplies
   14. Sample regulatory packet for a clinical research project or study
   15. Regulatory, patent and legal considerations in protocol design
   16. Scientific misconduct and its consequences
4. Management of Research Sites
   1. Basic procedures and tasks needed to implement a clinical study including recruiting, budgeting, and timelines
   2. Qualifications for the investigator, study coordinator, and other site personnel in conducting research in Phase I, Phase II, and Phase III clinical trials
   3. Responsibilities and roles of key personnel participating in the management of a research site
   4. Regulatory/essential documents required of a research site
   5. Databases, logs, and files utilized in the maintenance of a study site
   6. Differences between the roles of a site coordinator and a monitor in the preparation, maintenance, and submission of required reports
5. Recruitment, Enrollment and Retention of Study Subjects
   1. Ethical considerations involved in human experimentation
   2. Subject recruitment plan 
   3. Informed consent from study participants
   4. Subject participation according to established protocols
   5. Collection of specimens for submission to central collection laboratories
   6. Monitoring dosage modifications and treatment calculations for compliance
   7. Identifying and reporting adverse drug reactions according to study guidelines and reporting requirements
   8. Preparation and maintenance of required records and follow-up on protocol subjects
   9. Regulatory document binders; study files and manuals with new studies; amendments; and closure notices
6. Data Collection and Management
   1. Purpose of source documentation
   2. Source document review process
   3. Case report form completion
   4. Characteristics of high-quality data
   5. Case report form corrections, errors and queries
   6. Electronic data capture
   7. Data security
   8. Internal quality assurance
   9. Audit preparation
   10. Archiving data