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Job Summary:
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.
Essential Functions and 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.
Qualifications:
Graduate of an accredited nursing program required; Bachelor's degree in Nursing (BSN) preferred.
Valid RN License from Virginia or reciprocal compact state required.
AHA BLS for Healthcare Providers required.
Minimum of two years previous research experience preferred.
Excellent oral and written communication skills, computer literacy and a 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.
MWHC will not discriminate in its employment practices due to an applicant's race, color, religion, sex, sexual orientation, gender identity, national origin, and veteran or disability status (EOE). We are also committed to equitable and transparent compensation practices and comply with all applicable pay transparency and pay equity laws.
Required
Physical Requirements: Constant (67-100% of workday) walking, standing, use of arms and hands; frequent (34-66% of workday) bending, stooping, kneeling, and squatting; ability to lift 35 lbs.; ability to push and pull 20 lbs.; auditory and visual skills to include color determination; ability to work in confined spaces; ability to reach above/overhead.
Mental Requirements: Possesses critical thinking and analytical skills. Ability to multi-task. Ability to communicate effectively and collaborate with a multi-disciplinary team. Capacity to cope with difficult situations. Ability to tolerate irregular hours including evenings, nights, and weekends.
Environmental Requirements and Exposure Hazards: Potential risk of exposure to radiation and toxic chemicals. Potential for exposure to bloodborne pathogens; must be able to wear appropriate personal protective equipment.
*Clinical positions in Mary Washington Home Health and/or Hospice must also meet driving requirements.
“It is the policy of Mary Washington Healthcare to provide reasonable accommodations to qualified individuals with a disability who are applicants for employment or Associates.”
Compensation Pay Range:
$35.77 - $53.65
