RN Clinical Research Coordinator III

Exhibits advanced competencies required to conduct clinical research

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

perform 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 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

Education Required: Baccalaureate Degree in Nursing from an accredited School of Nursing, or a Bachelor’s degree in a health-related field

Education Preferred: Master’s degree in a health-related field

Licensing/ Certification

Licensure Required: Licensed Registered Nurse in the State of Virginia or eligible

Licensure Preferred: N/A

Certification Required: Basic Life Support (BLS) training for Healthcare Professionals

Certification Preferred: Clinical research certification (i.e., CCRP, CCRA, CCRC)

Minimum Qualifications

Years 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 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 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 staff

Combination 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 Requirements

Physical Demands: 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

Physical 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 Thinking

Emotional: Fast pace environment, Steady Pace, Able to Handle Multiple Priorities, Noisy Environment, Able to Adapt to Frequent Change