Principal Investigator | The Principal Investigator is ultimately responsible for all aspects of the study. Leads the research design and execution. Listed in protocol headers in CTMS, with visibility in the PI Console, differentiating them as the primary decision-maker and leader of the study. Functionality of this role in system: The staff member with Principal Investigator role is listed in the protocol header throughout OnCore. This code also determines which protocols a user with the PI Console permission can see in the PI Console. |
Study Site Contact | Serves as the main communication liaison for a research site, coordinating interactions and logistics in the absence of a centralized study contact model. Functionality of this role in system: Identified as the contact on the Site Information Portal (SIP) page in CTMS, distinct from other roles due to their primary focus on site-level communication. |
Primary Research Coordinator | Primary Research Coordinator. Acts as the lead in monitoring compliance and data quality in clinical trials. In CTMS, appears as the Protocol Contact, emphasizing their role in overseeing trial conduct, distinct from coordinators due to their monitoring and audit focus. Functionality of this role in system: Staff assigned the CRA role appear in the subject header in Subject Console and in the Subject Console > Protocols > Subject Protocol table as the Protocol Contact. |
Clinical Research Nurse | Specializes in patient care, usually in dedicated clinical research settings, administering treatments and monitoring health. Functionality of this role in system: Determines the staff member listed as the Clinical Research Nurse in the Patient Interval Report. |
Clinical Research Coordinator | Manages day-to-day trial operations, including administrative tasks and data collection. Their role is central to patient scheduling and protocol adherence, distinct from CRAs who focus more on monitoring and compliance. Functionality of this role in system: Determines the staff member listed as the Clinical Trial Coordinator in the Patient Interval Report. |
Clinical Research Nurse Coordinator | Research nurse that specializes in patient care, usually in dedicated clinical research settings, administering treatments and monitoring health. Also has study coordinator responsibilities. |
Treating Physician | Provides medical care to study participants, ensuring adherence to the treatment protocol. Identified in various forms in CTMS, distinct from nurses or coordinators due to their medical decision-making role. Functionality of this role in system: Staff with this role appear as Treating Physician in the Subject Registration Notice, Subject Search, and SAE form. |
Regulatory Coordinator | Manages the regulatory aspects of clinical research, ensuring compliance with laws, regulations, and guidelines. They prepare and submit necessary documentation to regulatory agencies. |
Data Coordinator | Manages the collection and entry of data in clinical trials. QA and operational, they ensure that data is accurately recorded and maintained in accordance with the protocol. |
Data Manager | Oversees the data management process, including data collection, validation, and analysis. They ensure the integrity and confidentiality of study data so accurate data can be extracted and valid/reproducible conclusions can be obtained. |
Data Monitor | Ensures the accuracy and completeness of clinical trial data through monitoring and auditing. They identify and resolve data discrepancies. |
Financial Coordinator | Manages the financial aspects of clinical research, including budgeting, billing, and financial reporting. |
Laboratory Coordinator | Oversees the laboratory components of clinical research, including sample collection, processing, and analysis. |
Coverage Analyst | Reviews clinical research protocols and related documents to determine insurance coverage and billing compliance for clinical trial participants. |
Quality Assurance | Focuses on ensuring that the clinical research is conducted and documented in compliance with quality standards, regulations, and protocols. |
Sub-Investigator | Assists the principal investigator in the scientific and technical aspects of the study. They often help with data collection and analysis. |
Research Advanced Practice Professional | A healthcare professional, often with an advanced degree, who participates in the clinical research process, possibly involving direct patient care or specialized assessments. |
Co-Investigator | Collaborates with the principal investigator in the design, conduct, and reporting of the research. They may share some responsibilities with the PI. |
Study Activation Specialist | Focuses on the initial set-up and activation of clinical trials, ensuring that all prerequisites for the start of the study are met. |
Budget Analyst | Responsible for the financial planning and analysis of research studies. They develop and monitor the study budget. |