RN Clinical Research Coordinator III

Schedule & Work Environment 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. Job Summary 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. Core Competencies Develops an internationally accepted standard of knowledge and understanding of the research process and related regulations Maintains membership in a minimum of two (2) professional organizations, department/hospital committees, or high‑profile activities Maintains an advanced level of knowledge related to anatomy, disease process, medical terminology, tests, and procedures in clinical areas of responsibility Exhibits a high level of proficiency in the Clinical Trial Management System and other electronic database/management systems per VCU Health/VCU requirements Develops a system for organizing, planning, and controlling workflow with meticulous attention to detail and ordering of priorities Functions independently and proficiently as described in the “summary of primary function” description with minimal supervision Study Activation and Closure Oversees operationalizing of investigator‑initiated, federal, and/or industry clinical research studies Fully participates in the design of study‑specific research processes Coordinates and facilitates site initiation visits Assists in evaluation of all potential clinical research studies, including their feasibility within the Health System Exhibits an expert knowledge of protocols, including background, rationale, methods, and description of investigational drug/device Understands and conveys knowledge of inclusion/exclusion criteria, visits, tests, procedures, and concomitant medications per protocol Performs informed consent process independently Maintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools, and related documents Maintains current inventory logs Identifies study‑specific tests and procedure protocols and facilitates any required training and/or validation Assesses protocol requirements for patient care and provides necessary instruction to clinical staff Collaborates with Principal Investigator to identify standard of care versus research‑only visits, hospitalizations, and required tests and procedures Assembles, updates and maintains study packets, including consent, inclusion/exclusion checklist, sponsor contact information, and other related information Coordinates study‑specific in‑services for appropriate clinical staff Completes study closure activities based on regulatory and sponsor‑specific requirements Patient Enrollment Oversees project enrollment patterns and goals in conjunction with Principal Investigators Diligently screens for patients in appropriate departments and participating outpatient offices Enters screen failures in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements Maintains contact with Principal Investigators and sub‑investigators to promote study and encourage patient enrollment Maintains preparation for patient enrollment at all times Promotes 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 follow Schedules participant study visits based on participant, investigator, and clinical staff availability Notifies and schedules sponsor clinicians and/or proctors for procedures or cases as necessary Pends orders for protocol required labs, tests, procedures, and medications as clinical permissions permit and according to VCU Health policy/SOPs Manages studies prospectively to prevent protocol deviations Enters patient enrollments and completes checklist in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements Communicates regularly with research and clinical team members to ensure smooth and accurate enrollments Maintains screening and enrollment logs and provides them to sponsor within established timeframes Data Collection Designs project‑specific case report forms if not sponsor provided Knowledgeable of case report forms and procedures for completion and correction Oversees timeliness and quality of project‑specific data collection Ensures all study documentation is accurately maintained, utilizing sponsor source documents or develops source documents as necessary Responds to data clarification requests adequately and in a timely manner Maintains a log of outstanding queries Maintains confidentiality of Protected Health Information (PHI) and keeps all records secure Requests charts and office notes from referring providers and investigators to retrieve/capture data Obtains all required signatures in a timely manner Collects, processes, stores, and ships biospecimens according to local and study‑specific requirements Manages Study Participant Follow‑Up Follows study participants, both inpatient and outpatient, throughout course of study Meets the timetable for protocol procedures and follow‑up schedule Ensures participants are scheduled for follow‑up appointments within required calendar windows Pends orders for all protocol‑required follow‑up labs, tests, procedures, and medications accurately as clinical permissions permit and according to VCU Health policy/SOPs Is present for all follow‑up appointments when presence facilitates study requirements and a positive experience for the participant Collects appropriate data during follow‑up visits utilizing acceptable source documentation Enters participant follow‑up visits and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements Monitors for adverse events, including review of study participant hospitalizations Informs participants of changes in protocol and adverse events; re‑consents participants as required Makes every attempt to locate participants for follow‑up and documents activity appropriately Collaborates with attending physician and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe Manages Monitoring Visits Coordinates and schedules monitoring and study close‑out visits Schedules conference room, Principal Investigator, regulatory personnel, pharmacist, and other required staff in advance for sponsor visits Provides complete source documentation for all data Ensures organized, complete study charts are available for review Is available to monitor for clarification and corrections as needed Communication and Problem‑Solving Anticipates obstacles and proactively develops solutions to achieve identified goals Is effective as the primary source for troubleshooting study‑specific obstacles and barriers Effectively collaborates with Principal Investigator to address barriers to project success Effectively 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 trials Communicates in a timely professional manner with investigators, research staff, colleagues, and University and Health System departments Answers pages, phone messages, and e‑mails in a timely manner, documenting communication as necessary Takes initiative to collaborate with interdisciplinary team members Coordinates with research study staff and Health System departments to efficiently maximize use of Health System resources Ensures accurate progress of the protocol from planning to closure Seeks direction, advice, and guidance from Principal Investigator, clinicians, Health System staff, and other applicable resources as necessary Additional Responsibilities Facilitates and attends study‑specific meetings and training to ensure smooth study processes from startup to close‑out Attends 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 processes Prepares agenda(s) and/or manages research meetings Participates in continual learning, Performance Improvement (PI) projects, and regulatory readiness Functions within the guidelines of VCU Health, VCU, HIPAA, OSHA, federal, state, and other regulatory agencies, including GCP and FDA guidelines Participates in VCU Health/VCU quality assurance programs Acts as a liaison and “Good Will Ambassador” between the research department, provider practices, Health System, and clinical and research staff Trains and mentors less experienced research team members Ensures all regulatory documents and correspondence are submitted to regulatory personnel in a timely manner Assists in recruiting and interviewing potential candidates for research positions Plans and designs new forms/flowsheets to be used in research activities Performs other duties as assigned and/or participates in special projects to support the mission of clinical research at VCU Health Aids other team members as needed/requested Accepts alternate assignments, as required Completes one (1) special project or presentation per year that impacts clinical research at VCU Health/VCU Patient 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 Qualifications Baccalaureate Degree in Nursing from an accredited School of Nursing, or a Bachelor's degree in a health‑related field (required) Master's degree in a health‑related field (preferred) Licensing / Certification Licensed Registered Nurse in the State of Virginia or eligible (required) Basic Life Support (BLS) training for Healthcare Professionals (required) Clinical research certification (i.e., CCRP, CCRA, CCRC) (preferred) Minimum Qualifications 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 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 player. Ability 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 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 staff. 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 have periods of constant interruptions. 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 Requirements Lifting/Carrying (0‑50 lbs.), Push/ Pull (0‑50 lbs.), Push/ Pull (50‑100 lbs.), Stoop, Kneel, Squat, Balance, Bending. Work Position: Sitting, Walking, Standing. Additional Physical Requirements / Hazards 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 Thinking. Emotional: Fast pace environment, Steady Pace, Able to Handle Multiple Priorities, Noisy Environment, Able to Adapt to Frequent Change. EEO Statement EEO Employer/Disabled/Protected Veteran/41 CFR 60‑1.4. #J-18808-Ljbffr Virginia Commonwealth University Health Systems