PETRA MAKIA NFONOYIM
Katy,TX
Summary
Clinical Trial Manager and Board-Certified Nurse Practitioner with experience leading site management, clinical monitoring, and central monitoring across oncology, metabolic, and infectious disease studies. Oversees CRAs and central monitors, maintains CMP and risk assessment processes, and coordinates cross-functional teams to support site activation, enrollment, and database lock timelines.
Overview
3
3
Languages
1
1
Certification
17
17
years of professional experience
Work History
Project Manager
Wheel Healthcare Services
Remote, TX
04.2026 - Current
- Facilitated cross-functional healthcare project planning and delivery at Wheel Healthcare Services, ensuring alignment among stakeholders.
- Tracked project timelines, assigned tasks, and monitored milestone progress for active initiatives.
- Documented requirements, scope changes, and process updates for healthcare operations projects, enhancing clarity and project execution.
- Contributed to quality improvement efforts across patient service and administrative processes, driving better outcomes for patients and staff.
Clinical Trial Manager
Aveanna Health Care
, Texas
10.2024 - 04.2026
- Site Management & Monitoring Oversight: Oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity across multi-protocol clinical projects from post-activation through site closeout, including oversight of patient recruitment and milestone delivery.
- Coordinated with Study Start Up, Patient Recruitment, Data Management, and Pharmacovigilance to ensure timely delivery handoffs and achievement of study milestones, including site activation, enrollment, and database lock, while providing risk updates to project management and leadership.
- Risk Management & Study Tools: Develop and maintain clinical study tools and templates including the Clinical Monitoring Plan (CMP), review study scope of work and budget, and conduct Risk Assessment and Categorization (RAC) to identify critical data, process risks, and protocol execution risks with targeted mitigations.
- Oversaw and mentored clinical team members, managed staff assignments, and assessed process compliance and emerging risks to develop corrective action plans that ensured quality deliverables.
- Partnered with leadership in bid defense meetings and maintained client relationships to support add-on business generation and therapeutic area growth.
Local Trial Manager / Sub-Investigator
Pinnacle Clinical Research
, Texas
07.2023 - 10.2024
- Local trial management: Led local trial team activities for industry-sponsored oncology and metabolic trials, ensuring compliance with SOPs and regulations through effective project planning, recruitment strategies, risk management, and budget tracking, while maintaining 100% inspection readiness.
- Sponsor liaison & milestone delivery: Provided protocol-specific training to site staff, managed informed consent form compliance with SOPs and regulatory requirements, reviewed monitoring visit reports, and coordinated with sponsors to meet enrollment targets and database lock timelines.
- Evaluated complex safety datasets as Data Safety Monitoring Committee (DSMC) member, reported all Adverse Events (AE) and Serious Adverse Events (SAE) within required timelines, and supported protocol safety decisions for immunotherapy risk-benefit assessments.
Clinical Research Associate (CRA)
CR Clinical
, Texas
01.2021 - 06.2022
- Multi-Site Monitoring: Managed portfolio of 10+ investigative sites across multiple states, executing 50+ annual monitoring visits (SIV, RMV, COV) and central monitoring reviews in compliance with ICH-GCP, the stated monitoring strategy, and Clinical Monitoring Plan (CMP).
- EDC & Data Quality Management: Utilized EDC tools (Medidata Rave) and CTMS dashboards to resolve data queries, track site KPIs, and identify emerging risks, leading to reduced protocol deviations.
- TMF / ISF & Regulatory Compliance: Maintained Sponsor TMF and ISF documentation, conducted access and audit trail reviews, and ensured inspection-ready regulatory submissions aligned with global SOPs and sponsor specifications, facilitating compliance during audits.
Clinical Research Nurse
Houston Methodist Research Institute
Houston, TX
12.2019 - 01.2021
- Immuno-Oncology Trial Execution: Managed high-acuity oncology and vaccine trials across multi-site teams, coordinating investigational product protocols and T-cell therapy monitoring while managing site-level adverse events to uphold protocol compliance and safeguard patient safety.
- Safety & Regulatory Reporting: Investigated SAEs within required timelines, supported CRF development and EDC data entry, and ensured compliance with regulatory submissions and IEC/IRB documentation.
- Investigational Product Management: Coordinated complex medication protocols to uphold patient safety and ensure strict adherence to study protocols.
Registered Nurse – Oncology Unit
Methodist Hospital
Houston, TX
01.2016 - 12.2019
- Acute Oncology Care: Provided compassionate care to 40+ oncology patients weekly, including those undergoing surgery, radiation therapy, and clinical trials, enhancing patient experience and recovery.
- Medication Safety & Audits: Achieved 98% medication administration accuracy and facilitated internal and external audits, ensuring adherence to safety protocols and improving compliance.
- Provided direct patient care at the bedside across various hospital units. across Methodist Hospital units following physician orders.
- Dispensed prescribed medications to patients according to hospital protocols. and monitored patient responses using hospital protocols.
- Conducted thorough patient assessments and recorded findings in health records. and documented findings in electronic health records.
Oncology ICU Nurse (Travel Nursing)
Fastaff Travel Nursing
Thousand Oaks & San Jose, CA
02.2013 - 11.2015
- Provided high-acuity critical care for severely ill oncology patients across multiple California facilities, collaborating with physicians and specialty teams to implement tailored ICU treatment protocols.
- Delivered intensive care during Fastaff travel assignments in high-acuity ICU environments.
- Monitored ventilators, telemetry, and hemodynamic status for critically ill patients.
- Administered medications and titrated drips per ICU protocols and provider orders.
Clinical Research Coordinator
Mercy Hospital Oklahoma City
Oklahoma City, OK
01.2010 - 01.2013
- Coordinated patient screening, enrollment, and data management, achieving regulatory compliance through effective IRB/IEC submissions, informed consent preparation, protocol amendments, and study closeout across multiple concurrent trials.
Specimen Processor / Phlebotomist
Mercy Hospital Oklahoma City
Oklahoma City, OK
05.2009 - 11.2009
- Laboratory & Phlebotomy Operations: Executed venipuncture and processed specimens in high-volume hospital, maintaining accuracy and timeliness in sample handling.
Education
Master of Science in Nursing (MSN) - Nursing
University of Texas, El Paso
El Paso, TXMaster of Science - Human Resources
University of Oklahoma
Norman, OKBachelor of Science in Nursing (BSN) - Nursing
University of Langston
Langston, OKSkills
- Clinical oversight
- Protocol compliance
- Risk assessment
- Risk monitoring strategies
- Monitoring plan development
- Project lifecycle management
- Project monitoring tools
- Project management software
- Clinical trial systems
Personal Information
Title: MSN, AGACNP-BC | Clinical Trial Manager
Certification
- Board Certified Adult-Gerontology Acute Care Nurse Practitioner (AGACNP-BC)
- GCP (Good Clinical Practice) Certified
Affiliations
- Association of Clinical Research Professionals (ACRP) – Member
- American Nurses Association (ANA) – Member
- American Association of Nurse Practitioners (AANP) – Member
THERAPEUTIC AREAS
- Oncology & Hematology
- Phase I/Ib (Early Phase): Specialized in First-in-Human (FIH), dose-escalation (3+3 design), and safety/tolerability studies.
- Phase II (Proof of Concept): Managed efficacy and dose-finding trials for targeted therapies and Rare Disease Hematology.
- Phase III (Pivotal): Led large-scale, often international, confirmatory trials comparing new treatments against the standard of care for regulatory submission.
- Metabolic (MASH/MASLD)
- Phase IIa/IIb: Oversaw multi-center, double-blind trials focusing on histological endpoints, such as MASH resolution and fibrosis improvement.
- Phase III: Managed long-term (72+ week) global trials evaluating sustained efficacy and safety profiles for metabolic dysfunction-associated steatohepatitis.
- Infectious Disease (Vaccines)
- Phase I/II (Combined): Experience in accelerated, overlapping vaccine development timelines for COVID-19 and Influenza, focusing on safety and immunogenicity (antibody titers).
- Phase III: Directed large-scale efficacy trials (tens of thousands of participants) to assess vaccine protection against symptomatic disease and severe infection.
- Phase IV (Post-Marketing): Conducted surveillance and real-world effectiveness studies for approved vaccines to monitor long-term safety.
Languages
English
Native/ Bilingual
French
Native/ Bilingual
Spanish
Limited
Timeline
Project Manager
Wheel Healthcare Services
04.2026 - Current
Clinical Trial Manager
Aveanna Health Care
10.2024 - 04.2026
Local Trial Manager / Sub-Investigator
Pinnacle Clinical Research
07.2023 - 10.2024
Clinical Research Associate (CRA)
CR Clinical
01.2021 - 06.2022
Clinical Research Nurse
Houston Methodist Research Institute
12.2019 - 01.2021
Registered Nurse – Oncology Unit
Methodist Hospital
01.2016 - 12.2019
Oncology ICU Nurse (Travel Nursing)
Fastaff Travel Nursing
02.2013 - 11.2015
Clinical Research Coordinator
Mercy Hospital Oklahoma City
01.2010 - 01.2013
Specimen Processor / Phlebotomist
Mercy Hospital Oklahoma City
05.2009 - 11.2009
Master of Science in Nursing (MSN) - Nursing
University of Texas, El Paso
Master of Science - Human Resources
University of Oklahoma
Bachelor of Science in Nursing (BSN) - Nursing
University of Langston