Clinical Research Nurse-Full Time Days

Mary Washington Healthcare

1d•$36 - $54•Onsite

About The Position

The Clinical Research Nurse serves as a highly specialized, autonomous clinician responsible for delivering expert nursing care, study interventions, and comprehensive clinical assessments to patients enrolled in complex clinical trials. The Clinical Research Nurse will work under the supervision of Clinical Research management and Principal Investigator (PI) and collaborate with a multidisciplinary approach. This role requires advanced clinical judgment to bridge strict scientific protocols with acute, hands-on patient care.

Requirements

Graduate of an accredited nursing program required
Valid RN License from Virginia or reciprocal compact state required.
AHA BLS for Healthcare Providers required.
Excellent oral and written communication skills
Computer literacy
Proven ability to successfully interact with administration, physicians, patients and Associates.
Ability to interface with the public/community and work effectively with diverse groups and individuals.

Nice To Haves

Bachelor's degree in Nursing (BSN) preferred.
Minimum of two years previous research experience preferred.

Responsibilities

Assists with the conduct of a successful clinical trial, including determining feasibility, participating in sponsor site visits such as SEV, SIV, monitoring visits and study close-out visits, and corresponding with industry study sponsors.
Reviews medical records and screens potential research subjects to determine eligibility for enrollment, obtains informed consent, and conducts study visits per the study protocol.
Ensures study compliance with FDA regulations, ICH GCP guidelines, HIPAA standards, and study protocols.
Works with Information Services to build study treatment plans within the EMR system.
Maintains the protocol-specific schedule of research activities for study subjects including: IRT systems for randomization, maintaining study blind (if indicated), drug administration, collecting biospecimen samples, scheduling orders, performing EKGs and/or comprehensive physical exams; identifies abnormal findings and notifies PI.
Performs advanced clinical skills in collecting time-critical pharmacokinetic (PK) and pharmacodynamic (PD) blood sampling, meticulous handling, and specialized processing (e.g., refrigerated centrifugation, aliquoting, and prepare shipment according to the IATA guidelines).
Conducts direct patient care by performing a nursing assessment of patient health status, determines patient-specific needs and tailors nursing interventions, develops a plan for safely and effectively executing research activities set forth by the study protocol.
Utilizes expert clinical skills in maintaining peripheral IV access, as well as the assessment, care, and utilization of central venous access devices (e.g. PICC lines, implanted ports), and ensures strict adherence to aseptic technique and infection control standards.
Demonstrates advanced clinical competency in the administration of complex investigational products, including Phase III-IV intravenous (IV) infusions, biologic therapies, and immunotherapy.
Ensures patient receives safely calculated dosages, manages sequential infusions, and operates infusion pumps according to strict, time-sensitive protocol requirements.
Evaluates patient response to the study intervention, performs continuous, high-acuity monitoring during investigational infusion, recognizes and intervenes during potential infusion-related reactions, anaphylaxis, and toxicity.
Assesses for signs and symptoms of any drug-related adverse events and serious adverse events, notifies and collaborates with the PI to titrate or halt investigational medications based on real-time patient clinical status.
Educates patient to report any adverse effects.
Ensures all trial activities adhere to federal, state, and institutional regulations, including reporting adverse events and serious adverse events (SUSAR) to Institutional Review Boards (IRB) and study sponsors.
Acts as patient advocate as part of a multidisciplinary team of physicians, pharmacists, nurses, research team members, and other ancillary departments.
Collects and documents clinical data accurately within EMR system and EDC, resolves queries related to data entries, and maintains patient study binders.
Performs other related duties as assigned.