RN Clinical Research Coordinator III

**Schedule will flex and extend in response to clinical research demands, including occasional needs during the weekend and evening/night. Environment includes any location within the VCU Health enterprise where clinical research is conducted, including VCU Medical Center, Tappahannock Hospital, Community Memorial Hospital, and VCU Health affiliated centers and clinics**The Clinical Research Coordinator III is responsible for full project management of clinical research studies (including investigator-initiated and Phase I, II, III, and IV industry trials for adult and/or geriatric patients) within internationally accepted standards of knowledge and understanding of the clinical research process and related regulations. Position duties include administrative and clinical study initiation processes, project maintenance, enrollment of patients, designing of case report forms, data collection, managing study participant follow-up, coordination of monitoring visits, collaborative writing of protocols and reports, and other administrative duties as determined for the successful conduct of innovative clinical research projects. The Clinical Research Coordinator III is also expected to fully participate in the training of, and be a resource for, junior clinical research staff as well as University and Health System staff.Exhibits advanced competencies required to conduct clinical researchDevelops an internationally accepted standard of knowledge and understanding of the research process and related regulationsMaintains membership in a minimum of two (2) professional organizations, department/hospital committees, or high-profile activitiesMaintains an advanced level of knowledge related to anatomy, disease process, medical terminology, tests, and procedures in clinical areas of responsibilityExhibits a high level of proficiency in the Clinical Trial Management System and other electronic database/management systems per VCU Health/VCU requirementsDevelops a system for organizing, planning, and controlling workflow with meticulous attention to detail and ordering of prioritiesFunctions independently and proficiently as described in the "summary of primary function" description with minimal supervisionStudy activation and closureOversees operationalizing of investigator-initiated, federal, and/or industry clinical research studiesFully participates in the design of study-specific research processesCoordinates and facilitates site initiation visitsAssists in evaluation of all potential clinical research studies, including their feasibility within the Health SystemExhibits an expert knowledge of protocols, including background, rationale, methods, and description of investigational drug/deviceUnderstands and conveys knowledge of inclusion/exclusion criteria, visits, tests, procedures, and concomitant medications per protocolperform informed consent process independentlyMaintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools, and related documentsMaintains current inventory logsIdentifies study specific tests and procedure protocols and facilitates any required training and/or validationAssesses protocol requirements for patient care and provides necessary instruction to clinical staffCollaborates with Principal Investigator to identify standard of care versus research-only visits, hospitalizations, and required tests and proceduresAssembles, updates and maintains study packets, including consent, inclusion/exclusion checklist, sponsor contact information, and other related informationCoordinates study-specific in-services for appropriate clinical staffCompletes study closure activities based on regulatory and sponsor-specific requirementsPatient enrollmentOversees project enrollment patterns and goals in conjunction with Principal InvestigatorsDiligently screens for patients in appropriate departments and participating outpatient officesEnters screen failures in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirementsMaintains contact with Principal Investigators and sub-investigators to promote study and encourage patient enrollmentMaintains preparation for patient enrollment at all timesPromotes protocol compliance by being present in unit/clinic/office/lab/OR when the participant is seen or leaves guidelines for Principal Investigator or sub-investigator to followSchedules participant study visits based on participant, investigator, and clinical staff availabilityNotifies and schedules sponsor clinicians and/or proctors for procedures or cases as necessaryPends orders for protocol required labs, tests, procedures, and medications as clinical permissions permit and according to VCU Health policy/SOPsManages studies prospectively to prevent protocol deviationsEnters patient enrollments and completes checklist in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirementsCommunicates regularly with research and clinical team members to ensure smooth and accurate enrollmentsMaintains screening and enrollment logs and provides to sponsor within established timeframesData collectionDesigns project-specific case report forms if not sponsor providedKnowledgeable of case report forms and procedures for completion and correctionOversees timeliness and quality of project-specific data collectionEnsures all study documentation is accurately maintained, utilizing sponsor source documents or develops source documents as necessaryResponds to data clarification requests adequately and in a timely mannerMaintains a log of outstanding queriesMaintains confidentiality of Protected Health Information (PHI) and keeps all records secureRequests charts and office notes from referring providers and investigators to retrieve/capture dataObtains all required signatures in a timely mannerCollects, processes, stores, and ships biospecimens according to local and study specific requirementsManages study participant follow-upFollows study participants, both inpatient and outpatient, throughout course of studyMeets the timetable for protocol procedures and follow-up scheduleEnsures participants are scheduled for follow-up appointments within required calendar windowsPends orders for all protocol required follow-up labs, tests, procedures, and medications accurately as clinical permissions permit and according to VCU Health policy/SOPsIs present for all follow-up appointments when presence facilitates study requirements and a positive experience for the participantCollects appropriate data during follow-up visits utilizing acceptable source documentationEnters participant follow-up visits and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirementsMonitors for adverse events, including review of study participant hospitalizationsInforms participants of changes in protocol and adverse events; re-consents participants as requiredMakes every attempt to locate participants for follow-up and documents activity appropriatelyCollaborates with attending physician and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframeManages monitoring visitsCoordinates and schedules monitoring and study close-out visitsSchedules conference room, Principal Investigator, regulatory personnel, pharmacist, and other required staff in advance for sponsor visitsProvides complete source documentation for all dataEnsures organized, complete study charts are available for reviewIs available to monitor for clarification and corrections as neededCommunication and problem-solvingAnticipates obstacles and proactively develops solutions to achieve identified goalsIs effective as the primary source for troubleshooting study-specific obstacles and barriersEffectively collaborates with Principal Investigator to address barriers to project successEffectively educates University and Health System staff regarding the process for management of the segregation and routing of charges related to the treatment of patients enrolled in clinical trialsCommunicates in a timely professional manner with investigators, research staff, colleagues, and University and Health System departmentsAnswers pages, phone messages, and e-mails in a timely manner, documenting communication as necessaryTakes initiative to collaborate with interdisciplinary team membersCoordinates with research study staff and Health System departments to efficiently maximize use of Health System resourcesEnsures accurate progress of the protocol from planning to closureSeeks direction, advice, and guidance from Principal Investigator, clinicians, Health System staff, and other applicable resources as necessaryAdditional ResponsibilitiesFacilitates and attends study-specific meetings and training to ensure smooth study processes from startup to close-outAttends institutional research meetings and training (i.e., Research Town Halls, IRB webinars, etc) as needed to facilitate successful knowledge obtainment for continued competency in clinical research processesPrepares agenda(s) and/or manages research meetingsParticipates in continual learning, Performance Improvement (PI) projects, and regulatory readinessFunctions within the guidelines of VCU Health, VCU, HIPAA, OSHA, federal, state, and other regulatory agencies, including GCP and FDA guidelinesParticipates in VCU Health/VCU quality assurance programsActs as a liaison and "Good Will Ambassador" between the research department, provider practices, Health System, and clinical and research staffTrains and mentors less experienced research team membersEnsures all regulatory documents and correspondence are submitted to regulatory personnel in a timely mannerAssists in recruiting and interviewing potential candidates for research positionsPlans and designs new forms/flowsheets to be used in research activitiesPerforms other duties as assigned and/or participates in special projects to support the mission of clinical research at VCU HealthAids other team members as needed/requestedAccepts alternate assignments, as requiredCompletes one (1) special project or presentation per year that impacts clinical research at VCU Health/VCUPatient Population: Demonstrates the knowledge and skills necessary to provide equitable care appropriate to the age of the patients served on their assigned unit. Adults (18-64 years), Geriatrics (65 years and older)Employment QualificationsEducation Required: Baccalaureate Degree in Nursing from an accredited School of Nursing, or a Bachelor's degree in a health-related fieldEducation Preferred: Master's degree in a health-related fieldLicensing/ CertificationLicensure Required: Licensed Registered Nurse in the State of Virginia or eligibleLicensure Preferred: N/ACertification Required: Basic Life Support (BLS) training for Healthcare ProfessionalsCertification Preferred: Clinical research certification (i.e., CCRP, CCRA, CCRC)Minimum QualificationsYears and Type of Required Experience: Minimum of three (3) years of registered nurse experience. Minimum of two (2) years of clinical research experience. A relevant Master's degree may be considered in place of one of the required years of research experience.Other Knowledge, Skills and Abilities Required: Advanced knowledge of medical terminology and medical procedures. Ability to work under dynamic, intense circumstances. Demonstration of strong initiative and follow-through. Detail-oriented and self-motivated team playerAbility to prioritize and manage time effectively. Clear, concise, and respectful communication skills. Ability to provide training and guidance to junior clinical research staff and patient car staff. Exhibits and maintains a high skill level use of Microsoft Office.Other Knowledge, Skills and Abilities Preferred: Demonstrated skill in patient records review and abstraction. Demonstrated skill in protocol development Ability to manage clinical research staffCombination of education and experience may be considered in lieu of a degree.Working Conditions: Periods of high stress and fluctuating workloads may occur. General office environment. Required to car travel to off-site locations, occasionally in adverse weather conditions. Long-distance or air travel as needed- not to exceed 10% travel. May be exposed to high noise levels and bright lights.May be exposed to limited hazardous substances or body fluids. * May be exposed to human blood and other potentially infectious materials. * May have periods of constant interruptions. Other: Schedule will flex and extend in response to clinical research demands, including occasional needs during the weekend and evening/night. Environment includes any location within the VCU Health enterprise where clinical research is conducted, including VCU Medical Center, Tappahannock Hospital, Community Memorial Hospital, and VCU Health affiliated centers and clinics.Physical RequirementsPhysical Demands: Lifting/ Carrying (0-50 lbs.), Push/ Pull (0-50 lbs.), Push/ Pull (50-100 lbs.), Stoop, Kneel, Squat, Balance, BendingWork Position: Sitting, Walking, StandingAdditional Physical Requirements/ HazardsPhysical Requirements: Manual dexterity (eye/hand coordination), Maneuver weight of patients, Hear alarms/telephone/tape recorder, Reach above shoulder, Repetitive arm/hand movements, Finger Dexterity, Color Vision, Acuity - far, Acuity - near Hazards: Depth perception, Use of Latex Gloves, Exposure to Toxic/caustic/chemicals/detergents, Exposure to moving mechanical parts, Exposure to x ray/electromagnetic energy, Gaseous risk exposure Mental/Sensory - Emotional Mental / Sensory: Strong Recall, Reasoning, Problem Solving, Hearing, Speak Clearly, Write Legibly, Reading, Logical ThinkingEmotional: Fast pace environment, Steady Pace, Able to Handle Multiple Priorities, Noisy Environment, Able to Adapt to Frequent ChangeEEO Employer/Disabled/Protected Veteran/41 CFR 60-1.4.

Created: 2026-04-19