Clinical Research Nurse, Clinical Operations

Commonwealth of Virginia

Richmond, VA

JOB DETAILS
SKILLS
Adobe Product Family, Advertising, Analysis Skills, Best Practices, Cancer, Case Report Form (CRF), Cerner, Certified Radiologic Nurse (CRN), Clinical Advice, Clinical Competency, Clinical Data Collection, Clinical Data Management, Clinical Nursing, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Conferences, Data Analysis, Data Collection, Data Entry, Data Management, Data Processing, Data Recovery, Disease, Disease Investigation, Documentation, Documentation Standards, Electronic Data Capture (EDC), Electronic Medical Records, Epic Systems, Equity Securities, Feasibility Analysis, Federal Laws and Regulations, GCP (Good Clinical Practices), Healthcare, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Investment Management, Leadership, Maintain Compliance, Mentoring, Microsoft Access Database, Microsoft Excel, Microsoft Outlook, Microsoft Visio, Microsoft Word, National Institutes of Health (NIH), Oncology, Operations Management, Operations Research, Organizational Skills, Problem Solving Skills, Process Flow, Registered Nurse (RN), Regulations, Research Administration, Research Nursing, Research Skills, Society of Clinical Research Associates (SoCRA), State Laws and Regulations, Technical Research, Training/Teaching, Tuition Fees, University/School Policies, XML (EXtensible Markup Language)
LOCATION
Richmond, VA
POSTED
30+ days ago

Advertising Summary

A Clinical Research Nurse (CRN) supports Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical research studies or protocols. Active clinical licensure is required for duties expected to be directly performed by the Clinical Research Nurse. At Massey, the CRN has more complex and intensive participant contact in a clinical setting requiring an individual with high levels of clinical competency to perform the research-related study work.

In addition to performing clinical skills associated with research studies, typical duties of a CRN include:

  • Assist the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection
  • Serve as patient/participant recruiters and perform a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data

A CRN may work independently or as a member of a team. They work under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager or the PI as appropriate.

Unit Massey Comprehensive Cancer Center MBU Department Massey Clinical Trials Office

Department Summary Massey Comprehensive Cancer Center

Mission To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research, person-centered care across the continuum from prevention through survivorship, community integration, and training the next generation of community-centric researchers and healthcare professionals.

Vision To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all.

Duties & Responsibilities Benefits All full-time university staff are eligible for VCUs robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, granted up front, 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.

Up to 5 remote days per month upon successful completion of training and leadership approval.

Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester.

Professional development opportunities encouraged and offered for employees as part of annual career development, e.g., certifications, seminars, courses, annual conferences, mentorship.

28 Vacation Days, 12 State Holidays, and 4 Days to volunteer.

Medical, Dental, and Vision Health Benefits to meet the needs of employees and their eligible family members from the Commonwealth of Virginia, as well as optional FSAP.

Participation in the Virginia Retirement System (VRS) and other retirement saving options.

Parental and Caregiver Leave, Short-Term Disability, STD, Disability Insurance, Voluntary Long-Term Care Insurance, and Employee Assistance Program.

Massey Comprehensive Cancer Center

Mission To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research, person-centered care across the continuum from prevention through survivorship, community integration, and training the next generation of community-centric researchers and healthcare professionals.

Vision To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all.

Position Primary Purpose and General Responsibilities A Clinical Research Nurse (CRN) supports Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical research studies or protocols. Active clinical licensure is required for duties expected to be directly performed by the Clinical Research Nurse. At Massey, the CRN has more complex and intensive participant contact in a clinical setting requiring an individual with high levels of clinical competency to perform the research-related study work.

In addition to performing clinical skills associated with research studies, typical duties of a CRN include:

  • Assist the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection
  • Serve as patient/participant recruiters and perform a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data

A CRN may work independently or as a member of a team. They work under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager or the PI as appropriate.

This role reports in-person in downtown Richmond with the flexibility to work hybrid, 5 days a month, post-review, 3-6 months training and manager approval. Each CRN reports to a Clinical Operations Manager who oversees disease working group-specific teams within the Clinical Research Operations Unit.

Recruitment, Enrollment, Retention, and Data Collection A CRN drives study coordination and regulatory management with participant recruitment, enrollment, tracking, data collection, data processing, resolution of discrepancies, queries, etc., verification, case-finding, evaluation, abstraction of source documentation, case report form completion, database use, management, data abstraction, organization, and archiving of data in the study database for research studies.

A CRN leads development of best practice guidance and work aids for their respective research team for all data management, documentation, following standard practice guidelines, utilizing multiple data capturers, retrieval systems, and interacting with various healthcare delivery systems to identify, track, evaluate, collate, analyze, submit subject data.

Data may include but is not limited to paper data, electronic data, and biological specimens.

Serve as a lead research coordinator for an emerging central coordinator pool, work with leadership to lay the groundwork for expanding a coordinator pool and overall portfolio staffing and management.

Maintain advanced understanding of clinical research management duties from initiation to closeout, including but not limited to federal and state laws and regulations, sponsor guidance, as well as university policies and compliance notices, with the ability to consistently interpret and apply accurately.

Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications, as well as any other mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials, and the NIH Human Subjects Protection training, as required.

Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB-approved protocols.

Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards, institutional operational research objectives, and ethical obligations.

Serve as an ongoing resource providing information and expert advice on clinical research for the research team, including but not limited to the clinical study team, coordinator, peer Clinical Research Nurses, Clinical Research Coordinators, Clinical Data Manager, Sponsors, and PI, with other duties as assigned.

Qualifications

Minimum Qualifications

  • Bachelors degree in Nursing and active clinical RN licensure
  • 2 years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with the ability to learn basic data entry, understand complex protocols, and motivation to learn the foundation of at least one oncology disease area
  • 2 years of experience with various clinical research or healthcare technologies, including but not limited to EDC software, XML, OnCore, EMR, Cerner, or EPIC, RedCap, DEEP6
  • Advanced proficiency with Microsoft Excel, Word, Access, Outlook, Visio, Smartsheets, and Adobe, with the ability to adapt to a range of database applications
  • Interest in working in a fast-paced, demanding environment and adapt to changing client status, regulations, and work environment
  • 2 years of demonstrated professional knowledge of medical oncology, clinical research, and/or disease working group terminology
  • Ability to provide own transportation to meet with patients within the service area, downtown Richmond, Stoney Point, etc., and attend all meetings within service areas and at training locations

Preferred Qualifications

  • Masters degree or equivalent combination of education, experience, and training
  • 3 years of relevant experience supporting data management activities with an exposure to data processes and flow or equivalent combination of education, training, and experience with basic data entry, complex protocols, and the foundations of at least one oncology disease area
  • 1 year of experience with research studies, interpreting complex protocols, subject records, and federal, state, local regulations
  • 1 year of current knowledge of oncology, cancer treatment, and care
  • 3 years of evidence of effective communication with research participants and/or patients on clinical trials
  • Collaborative Institutional Training Initiative (CITI) Training or knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas or equivalent combination of education, experience, and training
  • Certification from the Society of Clinical Research Associates (SOCRA), the Association of Clinical Research Professionals (ACRP), or CRA certification for Research Administration

Salary Range Commensurate with experience, minimum of $68,000 Benefits All full-time university staff are eligible for VCUs robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, granted up front, 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 Hours per Week 40 Restricted Position No ORP Eligible No Flexible Work Arrangement Hybrid

About the Company

C

Commonwealth of Virginia