We are seeking a highly skilled Infusion Nurse - Pharmacy to serve as a key member of the research team, supporting patient care, investigational product preparation, and clinical study coordination.
This role partners closely with the site pharmacist, investigators, and study coordinators to ensure safe administration, accountability, and documentation of investigational products while maintaining the highest standards of patient safety, protocol compliance, and regulatory adherence.
Job Responsibilities
Patient Care & Clinical Procedures
- Perform venipuncture, IV line placement, and protocol-specific clinical procedures
- Administer investigational product infusions and monitor patients throughout treatment
- Collect vital signs, ECGs, and clinical samples per protocol requirements
- Provide patient education regarding study procedures, risks, and follow-up care
- Monitor and escalate safety concerns appropriately
Investigational Product Preparation & Pharmacy Support
- Collaborate with the pharmacist to receive, prepare, mix, and dispense investigational medications
- Maintain strict investigational product accountability including documentation, temperature monitoring, and reconciliation
- Support sponsor monitor visits, audits, and regulatory inspections
- Ensure storage, handling, and preparation meet protocol and sponsor standards
Clinical Research Coordination
- Assist with informed consent discussions and documentation
- Complete source documentation and Case Report Forms (CRFs) accurately and timely
- Support study visit scheduling and patient follow-up
- Enter and manage study data within research systems
- Report adverse events, protocol deviations, and safety concerns
- Participate in study start-up, monitoring visits, and close-out activities
Collaboration & Compliance
- Partner with the Principal Investigator, Sub-Investigators, Pharmacist, CRCs, and sponsors
- Follow ICH-GCP, FDA, HIPAA, and site SOP requirements at all times
- Participate in sponsor calls, study meetings, and staff training initiatives
- Support overall study integrity and patient safety standards
What We're Looking For
- Strong clinical nursing skills within a research environment
- Experience administering infusions and managing IV therapies
- Knowledge of investigational product handling and accountability
- Familiarity with clinical research documentation and regulatory standards
- Excellent communication and patient interaction skills
- Ability to multitask and operate in a fast-paced study environment
- Proficiency in clinical systems, EDC platforms, and Microsoft Office
Requirements
Required Qualifications
- Active Registered Nurse (RN) license in good standing
- 3-5 years of clinical research experience (Research Nurse or CRC capacity)
- Demonstrated competency in blood draws, IV access, infusion administration, and medication preparation/mixing
- Knowledge of ICH-GCP, FDA regulations, and IRB processes
- Experience supporting investigational product management
Nice to Have (Not Required)
- Research pharmacy or investigational drug accountability experience
- Clinical Research Certification (ACRP or SOCRA)
- Infusion therapy background
- Experience supporting drug accountability audits or inspections
