Clinical Research Nurse

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. 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 elevate 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 elevate 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, #J-18808-Ljbffr Virginia Commonwealth University School of Medicine