Advertising Summary: Virginia Commonwealth University (VCU)
School of Medicine is a premier academic medical center located in
the heart of Richmond. Accounting for almost half of VCU’s
sponsored research, the School of Medicine is internationally
recognized for patient care and education. Virginia Commonwealth
University is an equal opportunity employer.
https://vcujobs.com/why-richmond
Unit: School Of Medicine MBU
Department: Clinical Research Office
Duties & Responsibilities:
The School of Medicine (SOM) Office of Research Administration is
seeking an experienced registered nurse with strong clinical
judgment and clinical research coordination skills to join the
School of Medicine Clinical Research Office (SOMCRO). This position
supports SOM investigators conducting clinical research across
inpatient and outpatient settings and provides protocol-directed
nursing care to participants enrolled in studies of varying
therapeutic areas and levels of complexity. The role offers an
opportunity to contribute to a growing central clinical research
program while advancing professionally in research nursing and
clinical trial management.
The Clinical Research Nurse will manage an assigned portfolio that
may include early-phase, investigational new drug, cellular or gene
therapy, immune effector cell, and other high-acuity studies. The
complexity of work may involve apheresis, conditioning regimens,
administration of investigational products, intensive inpatient and
outpatient safety monitoring, time-sensitive pharmacokinetic and
biomarker collections, and long-term participant follow-up. The
nurse will perform only those clinical activities authorized by the
protocol, VCU and VCU Health policy, professional scope of
practice, documented delegation, provider orders, and verified
competency.
Because research visits and participant needs do not always occur
during standard business hours, occasional evening, weekend,
on-call, or schedule-shift coverage may be required. Regular work
hours will generally follow the needs of the assigned studies, but
the nurse must be able to respond to time-sensitive clinical or
safety issues and support cross-coverage when appropriate.
This position reports to the Sr. Program Manager of SOMCRO Clinical
Research Operations. Key responsibilities include:
- Maintain an advanced understanding of clinical research nursing
and study management responsibilities from feasibility and
activation through study conduct, follow-up, and close-out.
Provide protocol-directed nursing care and clinical research
coordination for an assigned portfolio of studies involving a
variety of diseases, conditions, care settings, and participant
acuity levels.
Apply nursing assessment and critical-thinking skills to
recognize changes in participant condition, promptly escalate
concerns, and support safe, compliant research participation.
Maintain current CITI credentials for Human Subjects
Protection, Good Clinical Practice (GCP), and other institutional,
clinical, and sponsor-required training and competencies.
Understand and adhere to IRB requirements, the approved
protocol and consent, investigational-product requirements, HIPAA,
applicable federal and state regulations, and VCU and VCU Health
policies.
Serve as a clinical resource to investigators, research
coordinators, nursing units, ancillary departments, participants,
and caregivers regarding protocol requirements and research-related
care.
Work collaboratively within the SOMCRO pool, participate in
cross-training and cross-coverage, and help develop standardized
clinical workflows and research-nursing practices.
Core Responsibilities:
Clinical Research Nursing and Participant Care
- Review and understand assigned protocols, investigator
brochures, pharmacy or product manuals, schedules of activities,
toxicity-management guidance, and other study documents. Translate
requirements into safe, workable participant-care plans and visit
workflows.
- Evaluate inpatients and outpatients for potential participation
using protocol eligibility criteria; obtain and verify relevant
medical history, medications, laboratory results, and clinical
findings in collaboration with the principal investigator and study
team.
- Support the informed-consent process, confirm that consent is
obtained before study procedures, assess participant understanding,
document the process accurately, and help ensure ongoing consent
throughout participation.
- Perform protocol-required nursing assessments and procedures
within demonstrated competency, which may include vital signs,
focused nursing and neurologic assessments, electrocardiograms,
phlebotomy, specimen collection, medication reconciliation, and
participant-reported outcome support.
- Overseeing the administration of protocol-required
premedications, supportive medications, investigational products,
chemotherapy or other study interventions when authorized by
provider order, protocol, delegation, licensure, institutional
policy, and verified competency. Independently verify participant,
product, dose, route, timing, and required pre-administration
criteria with the appropriate clinical team.
- Coordinate complex treatment sequences that may include
apheresis, product manufacturing and release, bridging therapy,
conditioning or lymphodepletion, investigational-product infusion,
hospitalization, outpatient surveillance, and long-term follow-up.
Maintain required chain-of-identity and chain-of-custody
documentation for cellular products and biospecimens.
- Monitor participants before, during, and after study
intervention for infusion reactions, hypersensitivity, infection,
organ dysfunction, and other treatment-emergent toxicities. For
immune effector cell studies, recognize and promptly escalate
potential cytokine release syndrome, immune effector
cell-associated neurotoxicity syndrome, immune effector
cell-associated hemophagocytic syndrome, and other protocol-defined
events of special interest.
- Initiate appropriate nursing actions and emergency response
within scope and institutional policy; notify the investigator and
clinical care team without delay; facilitate additional evaluation,
transfer, hospitalization, or higher level of care when indicated;
and document all assessments, communications, interventions, and
participant responses.
- Coordinate and perform time-sensitive collection of blood,
urine, PBMC, pharmacokinetic, pharmacodynamic, immunogenicity, and
biomarker samples. Ensure correct labeling, processing, storage,
shipment, requisition completion, and documentation of actual
collection times according to laboratory manuals and protocol
requirements.
- Educate participants and caregivers about study visits,
medication restrictions, infection precautions, symptom monitoring,
temperature or other home logs, emergency contacts, required
proximity or caregiver support, and when to seek immediate care.
Reinforce education throughout participation.
- Coordinate research care with inpatient and outpatient nursing
units, physicians, advanced practice providers, apheresis or
cellular therapy programs, Investigational Drug Service, pharmacy,
laboratory, radiology, cardiology, neurology, and other ancillary
services to prevent missed procedures and protocol deviations.
- Maintain participant confidentiality and provide culturally
responsive, trauma-informed, and participant-centered care while
supporting participant autonomy and safety.
Clinical Research Coordination, Documentation, and Compliance
- Manage day-to-day study activities for assigned protocols,
including feasibility, activation, recruitment, screening,
enrollment, treatment, follow-up, data management, monitoring,
amendment implementation, and close-out.
- Participate in protocol feasibility and operational planning.
Identify clinical-resource needs, nursing effort, required
competencies, participant-care risks, scheduling constraints,
facility needs, and ancillary-service dependencies for new studies
and amendments.
- Create and maintain accurate, contemporaneous source
documentation and research records in accordance with ALCOA
principles. Record study procedures, medication administration,
start and stop times, participant response, deviations, and
clinical communications in the appropriate research and medical
records.
- Collect, enter, and reconcile study data in electronic data
capture systems, OnCore, Epic, and other approved systems. Respond
to sponsor queries within required timelines and collaborate with
fiscal personnel to support accurate tracking of visits,
procedures, and billable events.
- Detect, document, and facilitate investigator assessment of
adverse events, serious adverse events, protocol-defined events of
special interest, pregnancies, medication errors, and other safety
information. Submit required reports to the sponsor and IRB within
applicable timelines, including immediate or 24-hour reporting when
required.
- Review laboratory, vital-sign, and other safety results for
completeness and timely investigator review. Track clinically
significant abnormalities and unresolved events until the
protocol-required or clinically stable endpoint is reached.
- Prepare or assist with IRB and regulatory submissions,
continuing reviews, amendments, safety reports, delegation and
training logs, essential documents, investigational-product
records, and other materials needed to keep study files complete
and audit-ready.
- Coordinate pre-study assessments, site-initiation visits,
monitoring visits, audits, sponsor meetings, and close-out
activities. Resolve findings and corrective actions in partnership
with the investigator, sponsor, and SOMCRO leadership.
- Identify and report deviations, missed procedures, clinical or
operational risks, and barriers to recruitment or retention.
Collaborate on root-cause review and corrective and preventive
actions when appropriate.
- Serve as a liaison among participants, caregivers,
investigators, sponsors, contract research organizations, VCU, and
VCU Health to manage expectations, communicate changes, and
maintain continuity of research care.
Quality, Training, and Operational Readiness
- Maintain readiness to perform assigned clinical skills through
VCU Health orientation, annual competencies, protocol training,
simulation, and sponsor-required certification. Do not perform a
clinical activity until required competency and delegation are
documented.
- Provide protocol and workflow education to research staff and
clinical units, including study-specific safety monitoring,
escalation pathways, specimen handling, investigational-product
requirements, and after-hours communication plans.
- Serve as a resource and mentor for clinical research
coordinators and other team members on participant safety, clinical
documentation, visit conduct, and the integration of research
procedures into routine care settings.
- Contribute to standard operating procedures, nursing work
instructions, checklists, emergency workflows, source tools, and
competency materials that improve consistency, transparency, and
audit readiness across the SOMCRO portfolio.
- Participate in internal quality reviews, monitoring, audits,
continuing education, cross-training, and process-improvement
initiatives. Incorporate lessons learned and emerging safety
information into study operations.
Accountability, Customer Service, and Team Collaboration
- Take ownership of assigned responsibilities, establish
priorities, anticipate deadlines and participant-care needs,
communicate barriers early, and follow tasks through
completion.
- Develop and maintain productive relationships with principal
investigators, participants, caregivers, clinical departments,
SOMCRO colleagues, sponsors, and other partners throughout VCU and
VCU Health.
- Communicate clearly, respectfully, and promptly; provide
accurate updates on study status, participant needs, safety
concerns, and operational issues while maintaining appropriate
confidentiality.
- Participate in cross-coverage and shared portfolio management
so that participant safety, protocol requirements, and study
continuity are maintained during absences or periods of high
demand.
- Promote a collaborative, inclusive, and service-oriented
environment consistent with VCU values and SOMCRO's commitment to
high-quality clinical research support.
Qualifications:
Minimum Qualifications
- This position may be filled at the Clinical Research Nurse RS
1, RS 2, or RS 3 level based on the selected candidate's
qualifications. Prior clinical research experience is not required
for appointment at the RS 1 level.
- Graduation from an accredited professional nursing program that
qualifies the applicant for Registered Nurse licensure. Associate
degree, nursing diploma, Bachelor of Science in Nursing, and
advanced nursing degrees may be considered in accordance with
university requirements.
- Current, unrestricted licensure or authorization to practice as
a Registered Nurse in the Commonwealth of Virginia, or eligibility
to obtain such licensure or authorization before the start
date.
- Candidates without prior clinical research experience must
demonstrate the ability and willingness to complete structured
research orientation, protocol training, Human Subjects Protection
and GCP training, and all study-specific clinical competencies.
Training will be provided for candidates appointed at the RS 1
level.
- Appointment at the RS 2 or RS 3 level will be based on
progressively advanced professional nursing, clinical research,
specialized clinical, study-management, independent
decision-making, and leadership experience consistent with VCU
classification standards.
- Current Basic Life Support certification. Ability to obtain and
maintain Advanced Cardiovascular Life Support and other clinical
competencies when required by the assigned studies or care
setting.
- Demonstrated competence in clinical assessment, medication
administration, recognition of clinical deterioration, escalation
of care, and accurate documentation. Ability to complete IV,
phlebotomy, infusion, chemotherapy, cellular-therapy, or other
competencies when required for assigned protocols.
- Knowledge of professional nursing standards and the ability to
integrate provider orders, protocol requirements, research
regulations, and institutional policy into safe participant
care.
- Excellent communication, writing, interpersonal,
organizational, time-management, and critical-thinking skills, with
strong attention to detail.
- Ability to set priorities, make timely decisions within scope,
and meet deadlines while managing multiple participants, visits,
studies, and competing clinical demands.
- Ability to work independently and collaboratively in a large,
complex, and fast-paced academic health system and to establish
productive relationships with clinical and research partners.
- Ability to complete mandatory VCU, VCU Health, protocol,
sponsor, CITI, GCP, NIH Human Subjects Protection, and clinical
competency requirements and maintain required access to clinical
and research systems.
- Ability to work occasional evenings, weekends, on-call periods,
or adjusted schedules and to travel between VCU or VCU Health
clinical locations as required by assigned studies.
- Demonstrated ability to work in and foster an environment of
respect, professionalism and civility with a population of faculty,
staff, and students from all backgrounds and experiences, or a
commitment to do so as a faculty member at VCU.
Preferred Qualifications
- Five or more years of professional nursing experience,
including direct experience coordinating industry-sponsored
clinical trials or complex investigator-initiated research at an
academic medical center.
- Experience with early-phase trials, investigational new drug
studies, CAR T-cell or other cellular and gene therapies,
hematology/oncology, bone marrow transplant, infusion nursing,
critical care, rheumatology, or lupus nephritis research.
- Experience administering chemotherapy, biotherapy,
investigational agents, or cellular products and monitoring for
cytokine release syndrome, immune effector cell-associated
neurotoxicity syndrome, severe infusion reactions, and other
treatment-related toxicities.
- Current Advanced Cardiovascular Life Support certification and
an ONS/ONCC Chemotherapy Immunotherapy Certificate,
cellular-therapy competency, or ability to obtain applicable
credentials.
- Experience with Epic, OnCore, Veeva SiteVault, electronic data
capture systems, research specimen workflows, and sponsor or
regulatory inspections.
Applicants must be authorized to work in the U.S., as we are unable
to sponsor or take over sponsorship of an employment Visa at this
time.
Position will remain open until filled. Applications received by
October 23rd, 2026 will be given priority consideration.
Salary Range: $73,500-$100,000 (commensurate with
experience)
Benefits : All full-time university staff are eligible for
VCU’s robust
benefits
package that includes comprehensive health benefits, paid annual
and holiday leave, generous tuition benefits, retirement planning
and savings options, tax-deferred annuity and cash match programs,
employee discounts, well-being resources, abundant opportunities
for career development and advancement, and more.
FLSA Exemption Status: Exempt
Restricted Position: Yes
ORP Eligible: No
Flexible Work Arrangement: Hybrid
University Job Title: 3408B - Clinical Research Nurse RS
Base
