Clinical Research Nurses
The Clinical Research Nurse, under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance with National, State and local regulations, Institutional Review Board (IRB) approvals, and DCGI policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, the clinical trial nurse also acts as study coordinator for limited studies.
Roles of Clinical Research Nurse includes:-
Providing nursing care to research study patients:
- Ensures compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
- Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
- Performs medical tests, including, but not limited to, vital signs, imaging studies, and electrocardiograms.
- Handling temperature monitoring of medicines.
- Performing medication to the participants like Counseling, Dosage calculation, Port needle insertion and care, Chemo medication, Bed side care, Discharge summary detailing to the participants.
- Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies Principle Investigator of findings/issues
- Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
- Documents medical data in patient chart to capture protocol requirements and update to all documents in Electronic Case Report Forms (ECRFs).
As Study Coordinator, ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Good Clinical Practices (GCP) guidelines etc.
- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
- Develops accurate source materials and ensures compliance from site staff.
- Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and DCGI databases.
- Ensures appropriate credentialing and training of the entire GCP team.
- Supports the regulatory staff in the maintenance of regulatory documents in accordance with Site SOP and applicable regulations
- Interfaces with research participants, to support efforts to determine eligibility and consenting of study participants according to protocol
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
- Ensures compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability
- Disburses investigational drug and provides patient teaching regarding administration, as necessary
- Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants
- Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
- Occasional travel to attend sponsor study training meetings as required.
- Conducting sponsor visits, auditing and site monitoring visits.