Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Elyza Guerrero

Dallas

Summary

Hello! I'm a dedicated and detail-oriented Clinical Research Professional with 15 years of experience in clinical research trials, and I bring a strong medical/healthcare background spanning 25 years. I possess proven expertise in leading and managing all phases of clinical trials (I-IV), collaborating with renowned physicians, and ensuring regulatory compliance (ICH GCP, FDA). My background includes significant experience in leadership roles within both research and medical settings. I am currently seeking a full-time opportunity where I can retire years down the line after leveraging my comprehensive skills in a leadership role, regulatory compliance role, Quality assurance/ Quality control position, CRA, clinical research/medical office management, Contracts/Budget, or a potential Project Management position. I am looking for my forever home where I can pass on my years of knowledge to further drive a company or site to a successful outcome, even if i have to travel or relocate.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Site Director

DM Clinical Research
Dallas, TX
05.2024 - Current
  • Oversaw all aspects of site operations, ensuring efficient and compliant conduct of clinical trials.
  • Managed and supervised site staff, including hiring, training, and performance management.
  • Developed and implemented site-specific policies and procedures to optimize workflow and resource allocation.
  • Ensured adherence to study protocols, GCP guidelines, FDA regulations, and company SOPs.
  • Collaborated with sponsors, CROs, and investigators to facilitate successful trial execution.
  • Monitored study budgets, managed finances, and ensured accurate and timely data collection.
  • Maintained effective communication with all stakeholders, including patients, sponsors, and regulatory agencies.
  • Implemented quality control measures to ensure data integrity and audit readiness.
  • Drove patient recruitment and retention strategies to meet enrollment goals.

Independent Contractor (CRA) & Clinical Research Consulting

Independant
Dallas
01.2020 - Current
  • Provided contract CRA and consulting services to CROs and Sponsors.
  • Reviewed clinical trial protocols for regulatory compliance.
  • Reviewed and redlined ICF forms for IRB submission and approval.
  • Expertise in country-specific rules and regulations for clinical trial phases.
  • Developed monitoring plans, managed data, oversaw projects, and handled contracts/budgets.
  • Educated site staff on GCP, ALCOA, QA/QC, and ICF.
  • Performed Safety Data Reviews (SDR).
  • Reviewed master files and regulatory documents for Sponsors and sites.
  • Conducted chart/subject binder reviews for audit preparedness.
  • Performed SAE/AE and deviation log reviews.
  • Managed blinded/unblinded drug administration policies and guidelines.
  • Developed unblinded plans for sites, CROs, and Sponsors.
  • Conducted data monitoring.
  • Assisted sites with Sponsor or FDA audits.
  • Instructed CRC and CRA classes.
  • Provided reliable assistance to ensure efficient, audit-ready clinical research trials.

Clinical Research Site Manager (Temp Position)

ZENOS Clinical Research
Dallas
01.2023 - 01.2024
  • Managed daily operations of clinical research studies under the direction of the Principal Investigator.
  • Oversaw office and staff to ensure operational success.
  • Communicated effectively with study patients, staff, and vendors.
  • Managed study start-up documentation, training, supplies, and timelines.
  • Liaised with CROs, CRAs, and IRBs.
  • Ensured compliance with FDA, GCP, and HIPAA regulations.
  • Maintained comprehensive knowledge of current studies, company SOPs, policies, and confidentiality agreements.
  • Hired and trained new staff.
  • Managed and conducted continuous staff training and meetings.
  • Ensured quality control of studies and study documents.

Cardiovascular Research Supervisor

Baylor Scott & White Heart Hospital
Plano
01.2021 - 01.2023
  • Provided day-to-day supervision of department-based Clinical Research staff.
  • Wrote and assisted in developing proposals, grants, contracts, and budgets.
  • Developed, negotiated, and monitored research project budgets.
  • Facilitated implementation of clinical research projects, ensuring quality and timely completion.
  • Developed new protocols and materials, provided input to Principal Investigators, and determined financial and clinical feasibility.
  • Managed projects assigned by physicians, including sponsor-initiated and physician-initiated trials.
  • Assisted with contract and budget negotiations.
  • Completed feasibility, contract, and regulatory forms, including ICF templates.
  • Prepared initial project submissions, amendments, and issue notifications for the IRB.
  • Managed department payroll.
  • Conducted staff one-on-ones, interviews, hiring, firing, and onboarding.
  • Managed site staff time.
  • Conducted meetings with physicians.
  • Managed SAE reports, continuing review reports, and other IRB submissions.
  • Reviewed staff submissions to ensure compliance with standards.
  • Oversaw case report form completion and coordinated sponsor audits.
  • Monitored assigned Clinical Research funds and processed invoices.
  • Monitored device issues and reported to Sponsors.
  • Managed immediate problem-solving for subject safety.
  • Assisted with device trial implantation surgeries and data collection.
  • Provided on-call support for emergency surgeries involving trials.
  • Performed phlebotomy and laboratory processing; troubleshot lab equipment; performed complex sample testing.
  • Ensured equipment calibration.
  • Administered IV infusions and excelled in difficult venipuncture.
  • Conducted ABI testing and Doppler assessments; obtained EKGs and trained staff.
  • Performed Holter monitor placement; obtained vital signs and calculated BMI.
  • Managed device trials, including TAVR, Heart Failure, Cardiology (Cath, PTCA), Electrophysiology (Pacemaker, AICD, loop recorder), Peripheral Vascular, Cardiovascular (CABG), and Mitral/Tricuspid trials.
  • Implemented QA/QC processes and prepared charts for audits.
  • Applied project management skills, including clear communication, problem-solving, critical thinking, and risk management.

Clinical Operations Supervisor II (Temp position)

Covance
Dallas, TX
01.2020 - 01.2021
  • Oversaw operations for a Phase 1 clinical trial facility with a focus on subject safety and high-volume laboratory testing.
  • Ensured appropriate staff training.
  • Oversaw numerous clinical trials with over 100 daily participants.
  • Reviewed resumes and interviewed potential candidates; managed onboarding.
  • Ensured comprehensive daily trial coverage and addressed staffing gaps.
  • Assisted with medication dosing.
  • Performed phlebotomy, obtained vital signs and EKGs, and obtained PK samples.
  • Recorded data from medical tests onto subject charts.
  • Analyzed multiple samples and collected tissue samples per protocol.
  • Attended meetings and training sessions.
  • Conducted daily quality assurance and quality control checks on charts and source documents.

Clinical Research Facility Site Director

Benchmark Research
San Angelo
01.2011 - 01.2020
  • Ensured smooth site operation for the Principal Investigator and the company.
  • Designed and implemented business strategies to meet clinic goals.
  • Ensured departmental compliance with legal policies, guidelines, and standards.
  • Ensured sufficient and qualified personnel.
  • Organized and managed patient care and administrative operations.
  • Ensured medical records compliance with state and federal laws.
  • Conducted employee reviews and provided performance feedback.
  • Planned and managed the clinic budget and approved payroll.
  • Acted as a liaison between physicians and subjects.
  • Managed clinical trials from start to finish, adhering to study protocols, ICH-GCP guidelines, FDA regulations, SOPs, and ALCOA-C standards.
  • Guided site teams in planning and monitoring clinical trial conduct.
  • Managed staff, facilitated training, and communicated job expectations.
  • Guided, supported, and disciplined staff.
  • Collaborated with internal and external stakeholders.
  • Developed and enforced site-specific systems, policies, procedures, and productivity standards.
  • Ensured effective communication and implementation of strategic goals.
  • Met sponsor participant targets and weekly, monthly, and quarterly goals.
  • Attended company meetings and prepared agendas.
  • Completed administrative paperwork.
  • Managed trial budgets and contracts; oversaw IRB submissions and recruitment plans.
  • Managed laboratory operations, including sample aliquoting and IATA-compliant shipments.
  • Developed site quality improvement plans and managed CRC competency training and testing.
  • Oversaw project management, trial management, staff management, and training.
  • Managed CTA/CDA completion and regulatory submissions.
  • Prepared sites for audits.

Operations Manager- Sleep Center, NucMed, Cardio

Del Rio Heart Institute and Diabetes Center
Del Rio, TX
01.2005 - 01.2011
  • Managed a medical practice with 4 physicians and 25 staff members.
  • Assisted physicians and nurses with vitals, phlebotomy, and laboratory procedures.
  • Assisted in opening and managing a sleep center.
  • Hired and trained new staff.
  • Performed and interpreted polysomnography testing.
  • Conducted nuclear and treadmill stress tests; downloaded and interpreted 24-hour heart monitors; administered EECP therapy.
  • Performed IV placement for nuclear testing patients and pacemaker interrogations.
  • Performed phlebotomy and various laboratory tests; analyzed results.
  • Managed a weekly Coumadin Clinic.

Education

Bachelor of General Studies - General Studies

Sul Ross University
Uvalde, TX
01.2007

Paramedic - Emergency Medical Services

Howard College
San Angelo, TX
01.2003

Associate of Applied Science - Applied Science

Howard College
San Angelo, TX
01.2002

Skills

  • Human resources management to include hiring, payroll, employee performance evaluations,conflict resolution, team building, etc
  • New hire onboarding & training
  • Time and workload management
  • Site operations- planning and oversight
  • Compliance management and continuous improvement
  • Protocol deviation submission, CAPA implementation as per my quality assurance plan
  • Academic protocol writing
  • Project management
  • Sponsor/CRO interactions for potential trials, feasability completion
  • Budgets/Contracts
  • Trial Invoicing/Billing
  • Vaccine trials- (Primary vaccinator, Blinded/Unblinded roles
  • ICF redline creation/submission
  • Source Document Creation
  • Phase I,II,III, IV trials to include indication, device, and vaccine experience
  • QA/QC of charts to include all regulatory documents
  • Data verification of CRF
  • Preparation for a Sponsor or FDA audit
  • Community Outreach
  • Recruitment & retention plans
  • Specialized in EP, TAVR, CHF, Cardiovascular, device trials
  • Polysomnography Interpretation
  • EKG & 24hr-72 hr holter monitor interpretation
  • IV Infusion
  • Pediatric and Geriatric Phlebotomy
  • Pacemaker Interrogation
  • EECP Therapy
  • Systems (Epic, Logician, RealTime, CRIO, Florence)

Certification

  • IATA Certification
  • ACLS Certification
  • GCP Certification
  • BLS Certification

Timeline

Site Director

DM Clinical Research
05.2024 - Current

Clinical Research Site Manager (Temp Position)

ZENOS Clinical Research
01.2023 - 01.2024

Cardiovascular Research Supervisor

Baylor Scott & White Heart Hospital
01.2021 - 01.2023

Independent Contractor (CRA) & Clinical Research Consulting

Independant
01.2020 - Current

Clinical Operations Supervisor II (Temp position)

Covance
01.2020 - 01.2021

Clinical Research Facility Site Director

Benchmark Research
01.2011 - 01.2020

Operations Manager- Sleep Center, NucMed, Cardio

Del Rio Heart Institute and Diabetes Center
01.2005 - 01.2011

Bachelor of General Studies - General Studies

Sul Ross University

Paramedic - Emergency Medical Services

Howard College

Associate of Applied Science - Applied Science

Howard College

Similar Profiles

CREATE PROFILE
Elyza Guerrero