Clinical Research Professional Roles in Research
Overview
Clinical Research Professionals (CRPs) at Penn are integral members of the research team. The goal is to have highly trained, competent an motivated individuals in these roles. Some of their job functions include:
- Data Collection, Analysis, or Monitoring
- Case Management Of Protocol Participants
- Recruitment And Enrollment Of Human Subjects
- Protection of Subjects And Subjects’ Rights
- Development of Informed Consent Documents
- Preparation of Adverse Event Experience Reports
- Construction or Monitoring Of Case Report Forms
- Maintenance of Drug Accountability Records
- Development of Grants And Budgets
- Preparation of Reports
- Educating Other Healthcare Professionals, Patients or Families About Clinical Trials
- Protocol Development
- Program Administration
- Auditing Research Program
- Regulatory document submissions and maintenance
Training of CRPs is largely competency based using the CTSA (Clinical and Translational Science Awards) Program followed by ACRP (Association of Clinical Research Professionals). The ACRP modules, depicted below, are supplemented with Penn specific content.
Roles
Clinical Research Operations
OVERVIEW: Clinical Operations refers to the activities that support the clinical trial process from start-up to close out. Clinical Operations professionals are tasked with the planning, implementation, management, and execution of the clinical trial process. This role includes clinical research assistants, clinical research coordinators and clinical research operations professionals.
TRAINING: for more information see Required Training section under Clinical Research Professionals.
Clinical Research Nursing
OVERVIEW: The specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings, and clinical specialties (International Association of Clinical Research Nurses. (2012) "Enhancing Clinical Research Quality and Safety Through Specialized Nursing Practice". Scope and Standards of Practice Committee Report)
TRAINING: for more information see Required Training section under Clinical Research Professionals.
Clinical Research Monitoring/ Quality
OVERVIEW: Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements. The clinical research monitor is the person with direct access to, and oversight, of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.
TRAINING: for more information see Required Training section under Clinical Research Professionals.
Clinical Research Regulatory Affairs
OVERVIEW: A Regulatory Affairs specialist is responsible for knowing and operating within the legal framework established for clinical research and product development of drugs and devices. This includes obtaining necessary approvals from local entities such as the IRB; and federal authorities such as the FDA to conduct research in humans. Regulatory Affairs also ensures essential documents are maintained and always inspection ready. Skills of a Regulatory Affairs Specialists include a basic understanding of research, project management, preparing submissions, and effective communication.
TRAINING: for more information see Required Training section under Clinical Research Professionals.
Clinical Research Data Management
OVERVIEW: This role manages research data, creation of datasets for investigators, performing data quality assurance checks, creation of new summary variables for analysis, and creation of data tables for reports and papers. This role provides general administrative support for research data, completion of data collection forms, extracting and entering required clinical data from medical records and patient research charts to Case Report Forms (eCRFs/CRFs).
TRAINING: for more information see Required Training section under Clinical Research Professionals.
Clinical Research Project Management
OVERVIEW: This role oversees the operation and execution of all aspects of a clinical research study. Includes recruitment of participants and implementation of objectives for each study
TRAINING: for more information see Required Training section under Clinical Research Professionals.