Summary
Overview
Work History
Education
Skills
Additional Information
Timeline
Generic

AMELIA A. NOUNES

LEAGUE CITY,TEXAS

Summary

Seasoned nursing professional offering proven clinical knowledge, natural interpersonal strengths and technical abilities. Knowledgeable about coordinating the research process and implementing research protocols via study requirements. Quality-focused and efficiency-driven leader.

Overview

22
22
years of professional experience

Work History

Research Nurse IV

UTMB – OB-GYN Perinatal Research Division
04.2023 - Current
  • Department Leadership: Internal Regulatory Compliance Monitor: Provide quality assurance monitoring, procedure compliance and research data quality for ongoing research studies
  • Meet with investigators quarterly to provide updates, knowledge, and tools for investigators to be more involved in responsibility of maintaining compliance as part of leadership role
  • Coordinates complex research projects that involve supervision of research activities
  • Schedule study visits and meetings related to studies
  • Maintains training for conduct of human subject research.
  • Work closely with PI, other healthcare professionals, and families of subjects to ensure standards of good clinical practice, IRB requirements, and state-federal regulations are being observed
  • Maintains ongoing productive working relationship with study monitors and responds to study related questions about participants, study activities, queries, drafting Note to Files and reconcile protocol deviations and Informed Consent Form issues.
  • Participate in Investigator meetings, Pre-site, and Site Initiation Visits for upcoming research studies.
  • Review goals and requirements of new protocols when Lead Coordinator. I have also planned and designed source documentation for protocols and adhere to protocols.
  • Coordinated study initiation of multiple MFMU (Maternal Fetal Medicine Units) Network and Industry studies: create enrollment logs, maintain regulatory study binders, ensure that staff is trained, documents up to date, obtain signatures for training records and delegation of authority logs from study personnel.
  • Organize and facilitate assisting PI in obtaining Informed Consent from study participants and document appropriately. Ensures Informed consent process is followed and documented appropriately.
  • Monitor enrollment goals and mentor and assist all clinical research personnel regarding enrollment and recruitment as needed.
  • Assess staffing needs based upon current research activity and implement changes in staffing as needed and update staff on accomplishing enrollment goals.
  • Performs procedures related to study requirements
  • Enters and maintains data into database
  • Assist in precepting and orienting new clinical research staff.
  • Maintains supply inventory and equipment and ensures return of test article & clinical supplies.
  • Obtain Vital Signs and perform phlebotomy; monitors participants’ labs; maintains temperature and QC logs per protocol compliance.
  • Completes accurate, concise, and legible documentation on all participant records and other source documentation and forms per protocol and maintaining drug documentation, reconciling study drug accountability.
  • Identify patient and family educational needs regarding treatment and follow-up on specific clinical research; identifies areas of health promotion, and coordinates and facilitates improvement through informal teaching.
  • Intervenes and recommends patient needs and/or changes as appropriate to the PI and other health professionals.
  • Provide training and guidance to research nurses and other research personnel and serves as resource to staff.
  • Perform proficient physical, pathophysiological, psychosocial, cultural, spiritual, learning needs, and/or age-appropriate nursing assessment of participants required by research project within scope of practice.
  • Complete travel requests and invoices for travel reimbursement as needed to obtain reimbursement.
  • Monitor reports and enrollment logs for invoicing for studies that take on as lead coordinator.
  • Adhere to internal controls established for department by following our department's Policies and Procedures and follow Good Clinical Practice Guidelines.
  • Conduct in-service to nurses and providers when new study initiated and proficiently serve as resource to clinical staff.
  • Reports adverse events appropriately and timely

Interim Research Nurse Manager

UTMB Perinatal Research Division
08.2022 - Current
  • Directs conduct of research protocols, provides direction and supervision to research team on initiating research study and protocol related activities
  • Coordinates schedules of research nurses and staff to ensure adequate coverage of protocols
  • Manages Human Resources activities: gives direct input for direct reports on training, professional development, mentoring, counseling, performance evaluations and merit increases
  • Provides leadership for programs(s)/projects(s) and promotes teamwork
  • Actively promotes professional development of self and others
  • Supervises support staff, participates in quality assurance activities, and demonstrates commitment to quality research projects
  • Mentors clinical research personnel regarding enrollment/recruitment
  • Manages timekeeping for department employees
  • Completes feasibility assessments and develops study budgets for NIH and industry funded projects
  • Manages conduct of research at all regional obstetric hospital and clinic sites- Galveston, Pearland, Pasadena, Dickinson, Angleton, Clear Lake and Sugarland
  • Develops and maintains harmonious professional and productive relationships system-wide; builds contacts important to achieving work goals; demonstrates diplomacy and tact
  • Serves as effective formal and informal leader of teams and groups; obtains commitment and cooperation; delegates effectively and, counsels and evaluates personnel within assigned areas
  • Builds and implements efficient workflows and system processes to meet research aims and effectively produce research outcomes
  • Promotes collaboration between clinicians and research scientists, internal and external to the University
  • Maintains relationships and coordinates collaboration among leaders of multidisciplinary teams including nursing, medical, pharmacy, clinical lab, scientific lab, business administration and regulatory
  • Prepares for and oversees federal and local regulatory agencies (FDA, NIH, UTMB Internal Regulatory etc.) audits and inspections, composes responses and prepares action plans to address findings
  • Manages research education and development; including training, and mentorship for staff
  • Manages on-going strategic plans, ensuring maintenance and stabilization of current infrastructure and planning for future growth and changes utilizing performance metrics and process improvement techniques
  • Coordinates emergency preparedness plans
  • Attends and participates in Investigator planning meetings, pre-site, and site initiation visits
  • Conducts Interviews
  • Leads and conducts division staff monthly meetings & agendas

Research Nurse III

UTMB, OB-GYN Perinatal Research Division
01.2018 - 04.2023
  • Same as Research Nurse II with the addition of:
  • Department Leadership: Internal Regulatory Compliance Monitor: Provide quality assurance monitoring, procedure compliance and research data quality for ongoing research studies
  • Meet with investigators quarterly to provide updates, knowledge, and tools for investigators to be more involved in responsibility of maintaining compliance as part of leadership role
  • Coordinates complex research projects that involve supervision of research activities
  • Schedule study visits and meetings related to studies
  • Maintains training for conduct of human subject research
  • Work closely with PI, other healthcare professionals, and families of subjects to ensure standards of good clinical practice, IRB requirements, and state-federal regulations are being observed
  • Maintains ongoing productive working relationship with study monitors and responds to study related questions about participants, study activities, queries, drafting Note to Files and reconcile protocol deviations and Informed Consent Form issues
  • Participate in Investigator meetings, Pre-site, and Site Initiation Visits for upcoming research studies
  • Review goals and requirements of new protocols when Lead Coordinator
  • I have also planned and designed source documentation for protocols and adhere to protocols
  • Coordinated study initiation of multiple MFMU (Maternal Fetal Medicine Units) Network and Industry studies: create enrollment logs, maintain regulatory study binders, ensure that staff is trained, documents up to date, obtain signatures for training records and delegation of authority logs from study personnel
  • Organize and facilitate assisting PI in obtaining Informed Consent from study participants and document appropriately
  • Ensures Informed consent process is followed and documented appropriately
  • Monitor enrollment goals and mentor and assist all clinical research personnel regarding enrollment and recruitment as needed
  • Assess staffing needs based upon current research activity and implement changes in staffing as needed and update staff on accomplishing enrollment goals
  • Performs procedures related to study requirements
  • Enters and maintains data into database
  • Assist in precepting and orienting new clinical research staff
  • Maintains supply inventory and equipment and ensures return of test article & clinical supplies
  • Obtain Vital Signs and perform phlebotomy; monitors participants’ labs; maintains temperature and QC logs per protocol compliance
  • Completes accurate, concise, and legible documentation on all participant records and other source documentation and forms per protocol and maintaining drug documentation, reconciling study drug accountability
  • Identify patient and family educational needs regarding treatment and follow-up on specific clinical research; identifies areas of health promotion, and coordinates and facilitates improvement through informal teaching
  • Intervenes and recommends patient needs and/or changes as appropriate to the PI and other health professionals
  • Provide training and guidance to research nurses and other research personnel and serves as resource to staff
  • Perform proficient physical, pathophysiological, psychosocial, cultural, spiritual, learning needs, and/or age-appropriate nursing assessment of participants required by research project within scope of practice
  • Complete travel requests and invoices for travel reimbursement as needed to obtain reimbursement
  • Monitor reports and enrollment logs for invoicing for studies that take on as lead coordinator
  • Adhere to internal controls established for department by following department's Policies and Procedures and follow Good Clinical Practice Guidelines
  • Conduct in-service to nurses and providers when initiation of new study and proficiently serve as resource to clinical staff
  • Reports adverse events appropriately and timely

Research Nurse II

UTMB – OB-GYN Perinatal Research Division
07.2007 - 01.2018
  • Recruit, screen, enroll and evaluates subjects for various ongoing research studies within the department of Obstetrics/Regional Maternal Child Health Clinics
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Coordinates research process and implement research protocols via study requirements within the University
  • Educates subjects on study details assists in obtaining informed consent
  • Ensures studies are conducted in accordance with FDA and other regulatory agencies guidelines
  • Collect, process and ship biological specimens
  • Clinical trial data management
  • Monitors and evaluates patient response to protocol treatment
  • Provide patients with study medications
  • Safeguard the rights and well beings of study participants
  • Translate IRB documents from English to Spanish for IRB approval

Nurse Clinician III

UTMB Regional Maternal And Child Health Program
12.2005 - 07.2007
  • Assists in translating to high volume of Spanish-speaking patients and families
  • Work closely with members of interdisciplinary team in the clinic: Nurse Midwives, Nurse Practitioners, Physician Assistants, Medical Assistants, Patient Service Specialists, Residents, Faculty and Fellows
  • Complete patient intakes and identify nursing diagnoses and patient care needs
  • Executes provider’s orders for clinic patients
  • Medication administration and treatments including initiating IV therapy
  • Collect labs ordered and inform patient of lab results
  • Triage phone calls
  • Provide basic patient and family instruction and healthcare teaching based on identified learning needs utilizing evidence-base resources
  • Documentation of patient intakes, assessments, phone calls, medications, treatments, teaching, and procedures
  • Paid attention to detail while completing assignments.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Strengthened communication skills through regular interactions with others.

Nurse Clinician II

UTMB – Infant Special Care Unit
07.2004 - 12.2005
  • Developed specialty skills and training in intensive neonatal care nursery and completed six-month extensive internship program and cross-trained in several nurseries
  • Proficient in-patient assessments, planning, implementation, documentations, evaluation, monitoring, and providing daily care of assigned patients
  • Trained to assess patient status and notifying physicians of clinical changes, participate in patient rounds and execute physician’s orders for assigned patients
  • Proficient in administering, medications, treatments, basic patient / family healthcare and discharge teachings / instructions, analyzing and drawing lab work as ordered, identify nursing diagnoses, patient care needs, and performs routine technical procedures / skills needed in specialty area
  • Work closely with other members of interdisciplinary team on unit: Respiratory Therapists, Occupational Therapists, Physicians, Neonatal Nurse Practitioners, Neonatologist, Interns and Residents
  • Assists in translating to high volume of Spanish-speaking patient families

Clerk II

UTMB Faculty Group Practice
09.2001 - 08.2002
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Learned and adapted quickly to new technology and software applications.
  • Skilled at working independently and collaboratively in a team environment.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Participated in team projects, demonstrating ability to work collaboratively and effectively.

Education

Master of Science - Nursing

UTMB School of Nursing
Galveston, TX
08.2023

Bachelor of Science - Nursing

UTMB School of Nursing Galveston
Galveston, TX
04.2004

Graduate -

Ball High School
Galveston, TX
05.1998

Some College (No Degree) - Nursing

Galveston College
Galveston, TX

Skills

  • Systems proficient in:
  • Data entry, customer service, Microsoft Word, 10 key calculator, Excel, Velos/Oncore, PeopleSoft, EPIC, Kronos, Microsoft Office, Windows XP, Adobe Pro, CITI Program, Medrio, Redcap, Box, FileZilla, MIDAS, ResMed, Morgan Scientific, C/SOAP Follow-Up electronic data entry system (eDES), Q-global Pearson Clinical for Vineland-3, ASA24 (Automated Self-Administered Dietary Assessment Tool), Western Psychological Services (WPS) Online Evaluation System (OES)

Additional Information

  • CREDENTIALS / CERTIFICATIONS · Board Examination – July 2004 · License, State of Texas – July 2004 – 10-31-2023 · Neonatal Resuscitation Program – 2004 · Cardiopulmonary Resuscitation – 2-1-2023

Timeline

Research Nurse IV

UTMB – OB-GYN Perinatal Research Division
04.2023 - Current

Interim Research Nurse Manager

UTMB Perinatal Research Division
08.2022 - Current

Research Nurse III

UTMB, OB-GYN Perinatal Research Division
01.2018 - 04.2023

Research Nurse II

UTMB – OB-GYN Perinatal Research Division
07.2007 - 01.2018

Nurse Clinician III

UTMB Regional Maternal And Child Health Program
12.2005 - 07.2007

Nurse Clinician II

UTMB – Infant Special Care Unit
07.2004 - 12.2005

Clerk II

UTMB Faculty Group Practice
09.2001 - 08.2002

Master of Science - Nursing

UTMB School of Nursing

Bachelor of Science - Nursing

UTMB School of Nursing Galveston

Graduate -

Ball High School

Some College (No Degree) - Nursing

Galveston College

Similar Profiles

CREATE PROFILE
AMELIA A. NOUNES