Clinical Research Nurse
Position title: Clinical Research Nurse
Reports to: VP, Medical Affairs
Duties: Responsible for working under the guidance of the Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services.
Qualifications: Registered Nurse, bachelor’s in science of Nursing. Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel.
Experience: 1-3 years experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary or on job mandatory training will be required
- Assist Clinical Study Coordinators in any task as needed.
- Perform study procedures (g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators; Director, Associate Director, and Clinical Research Coordinators.
- Perform duties of Clinical Research Coordinator under the supervision of the Principal Investigator and Sub-Investigators; Manager, Clinical Operations; and Clinical Research Coordinators.
- Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness.
- Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.
- Develops a strategy for implementing study procedures in compliance with the study protocol.
- Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
- Responsible for maintaining emergency medication in the crash cart.
- Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.
- Assists in the screening of research subjects to evaluate their eligibility for a clinical study.
- Creates and performs QC procedures.
- Assists in the reconciliation of IPs and maintaining accountability.
- Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.)
- Shows desire and initiative to increase knowledge and skills in clinical research.