Independent Senior CRA · Contract Clinical Trial Monitoring

Precision monitoring for complex oncology trials.

Patricia M. Dunlea, BS, CAPM brings 25 years of clinical trial monitoring experience to pharma sponsors, CROs, and bio staffing firms, with a specialty in CAR-T and cellular gene therapy research.

25+

Years Experience

Phase I–III

All Trial Phases

CAR-T

Cell Therapy Specialist

17

Research Sites

What PMD Research Offers

Senior-level monitoring, delivered independently.

PMD Research provides contract clinical trial monitoring for oncology and cellular therapy studies on-site, remote, or hybrid in full compliance with ICH/GCP standards.

Ideal engagements

Phase I through III oncology and CGT studies requiring experienced, credentialed monitoring
CAR-T, NK cell therapy, and cellular gene therapy trials at major academic and community cancer centers
Short or long-term contracts directly with pharma sponsors, CROs, and bio staffing firms

ICH/GCP Compliance

Deep knowledge of FDA regulations and ICH guidelines applied consistently across US and Canadian trial sites.

CAR-T & CGT Specialist

Hands-on monitoring of chimeric antigen receptor T-cell and cellular gene therapy trials, a niche that demands rare specialized expertise.

Risk-Based Monitoring

Remote and on-site monitoring focused on data integrity, patient safety, and timely sponsor deliverables.

CAR-T Expertise

Specialized in the most advanced cancer treatments available.

CAR-T cell therapy engineers a patient's own T-cells to precisely target and destroy cancer cells, more targeted than chemotherapy and increasingly effective against blood cancers and solid tumors. Tricia has monitored multiple CAR-T and CGT trials across leading academic cancer centers nationwide.

Why this matters to sponsors:

Faster site activation and fewer deviations from a monitor who knows the therapy
Reduced ramp-up time on complex CGT protocols
Proven site relationships at top-tier oncology centers nationwide

Available Now

Ready for your next trial.

PMD Research works directly with pharmaceutical sponsors, CROs, and bio staffing firms. Currently available for new monitoring contracts nationwide.

BS, Environmental Science UMass Amherst
CAPM Certified Associate in Project Management
ICH/GCP Certified, US & Canada
North Easton, MA · Available Nationwide

About Tricia

25 years at the forefront of clinical research.

Patricia M. Dunlea is a Senior Clinical Research Associate with over two decades of experience managing complex clinical trials across oncology, pulmonary disease, dermatology, and medical devices. She founded PMD Research, LLC to bring that expertise directly to sponsors and CROs as an independent contractor.

Her career spans the most respected names in contract research including IQVIA, ICON/PRA Health Sciences, Premier Research, and Precision for Medicine, consistently delivering quality monitoring, ahead-of-schedule database locks, and strong site relationships.

Tricia's specialty in cellular and gene therapy, particularly CAR-T studies, places her at the cutting edge of oncology research. Sponsors include Pfizer, Bayer, Celgene, Kite/Gilead, Daiichi Sankyo, and NIH-funded platforms.

Site Experience

Tricia has worked with some of the most prestigious cancer research institutions in North America.

Massachusetts General HospitalBoston, MA

Dana-Farber Cancer InstituteBoston, MA

Memorial Sloan KetteringNew York, NY

Johns Hopkins Medical CenterBaltimore, MD

MD Anderson Cancer CenterHouston, TX

Mayo ClinicRochester, MN & Jacksonville, FL

Columbia University Medical CenterNew York, NY

Beth Israel Deaconess Medical CenterBoston, MA

Duke University Medical CenterDurham, NC

City of Hope National Medical CenterDuarte, CA

Sarah Cannon Research InstituteNashville, TN

Karmanos Cancer InstituteDetroit, MI

Levine Cancer InstituteCharlotte, NC

UNC Medical CenterChapel Hill, NC

UC San DiegoSan Diego, CA

Princess Margaret HospitalToronto, ON

Sunnybrook Health SciencesToronto, ON

Career History

A track record built trial by trial.

2024 – Present

PMD Research, LLC — Senior CRA, DCRI Contract

Managing 13 sites on a complex NIH-funded platform protocol. Completed recruitment ahead of schedule with an early database lock achieved.

2024 – 2025

IQVIA Biotech — Senior CRA III

Advanced oncology monitoring across multiple trials. Delivered an ahead-of-schedule database lock for a Phase II Head and Neck Cancer study.

2022 – 2023

Precision for Medicine — Senior Clinical Researcher

On-site and remote CAR-T monitoring across multiple studies and sponsors. Full ICH GCP/ISO14155 compliance.

2021 – 2022

Premier Research — Senior CRA, Remote

Full cycle monitoring focused on data integrity and patient safety. TMF/eTMF maintenance per ICH/GCP Section 8.

2013 – 2021

ICON Clinical Research, formerly PRA Health Sciences

Eight years as Senior CRA across Phase I through III oncology. Mentored junior CRAs and contributed to process improvement initiatives.

2002 – 2013

Quintiles, DePuy Spine and Earlier Roles

CRO, medical device, and in-vitro diagnostics work that built the regulatory and site management foundation for a 25-year career.

What PMD Research Offers

Full-service clinical trial monitoring for oncology and beyond.

Available for on-site, remote, or hybrid engagements across pharma sponsors, CROs, and NIH-funded programs.

On-Site Monitoring Visits

Site qualification, initiation, interim monitoring, and close-out visits conducted per the Clinical Monitoring Plan and ICH/GCP guidelines.

Remote Monitoring

Centralized and risk-based remote monitoring using sponsor CTMS, eTMF, and EDC systems. Efficient, thorough, and fully documented.

TMF Review & Maintenance

Comprehensive Trial Master File review to ICH/GCP Section 8 standards. Audit-ready essential documents, every time.

Source Data Verification

Meticulous SDV to confirm accuracy, completeness, and consistency with source documents. Critical for data integrity and regulatory submissions.

Investigational Product Accountability

IP receipt, storage, dispensing, and destruction review in full compliance with protocol and regulatory requirements.

Regulatory & Compliance Review

Review of IRB approvals, informed consent, and site regulatory files to ensure ongoing FDA and local regulatory compliance.

Tools & Systems

Fluent in the platforms your team already uses.

Experienced with EDC, IVRS, CTMS, and eTMF systems. Proficient in clinical project management tools and MS Office including Excel for data analytics and monitoring metrics.

Medidata Rave Veeva Vault Oracle Clinical CTMS eTMF MS Excel EDC Systems

Clinical Specialty

CAR-T Therapy & Cellular Gene Therapy

CAR-T therapy engineers a patient's own T-cells to recognize and destroy cancer cells. It is more targeted than chemotherapy and increasingly effective against blood cancers and solid tumors. Monitoring these trials demands specialized knowledge that few independent monitors possess. Tricia has that depth.

Therapeutic Areas

Broad oncology experience, deep CGT focus.

CAR-T / CGT

Multiple myeloma, follicular lymphoma, large B-cell lymphoma, ALL/AML, and prostate cancer across autologous and allogeneic cell therapy platforms.

Solid Tumors

Head and neck, glioblastoma, NSCLC, ovarian, uterine, breast, and prostate cancers across Phase I through III studies.

Other Areas

Pulmonary including asthma and COPD, dermatology, in-vitro diagnostics, and medical devices.

Select Study Experience

Trials monitored across leading sponsors.

Phase	Indication	Study	Sponsor
Phase I/II · CAR-T	Prostate Cancer	PSMA-targeted CAR-T cells in metastatic castration-resistant prostate cancer	Tceleron Therapeutics
Phase I/II · CGT	Multiple Myeloma	bb2121 in relapsed/refractory multiple myeloma	Celgene / BMS
Phase I/II · CGT	Advanced Cancers	CART-TnMUC1 in TnMUC1-positive advanced cancers	Kite / Gilead
Phase II	Head & Neck	Evorpacept plus pembrolizumab in advanced HNSCC (ASPEN-04)	ALX Oncology
Phase III	Prostate Cancer	Darolutamide (Nubeqa) in high-risk non-metastatic CRPC	Bayer
Phase II	AML	Quizartinib versus salvage chemotherapy in FLT3-ITD positive AML (QuANTUM-R)	Daiichi Sankyo
Phase II	Ovarian Cancer	Carboplatin/Gemcitabine plus BSI-201 in platinum-resistant ovarian cancer	Sanofi

Get In Touch

Let's talk about your next trial.

PMD Research is available for contract monitoring engagements with pharmaceutical sponsors, CROs, and bio staffing firms. Reach out to discuss your project.

tricia@pmdresearch.org

617-892-1906

LinkedIn Profile

North Easton, MA · Available nationwide

Fill out the form below and Tricia will respond within 1 to 2 business days to discuss your study needs and contract availability.