Maureen Tagsip
Gilbert
Summary
Dynamic clinical research professional with extensive experience in coordinating and managing complex clinical trials, emphasizing regulatory compliance and patient safety. Proven expertise in clinical trial management, meticulous record maintenance, and fostering team collaboration while demonstrating strong organizational and communication skills. Committed to enhancing protocol efficiency and ensuring data integrity, driving successful outcomes in clinical research environments. Adept at navigating challenges and implementing solutions that align with industry standards and best practices.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Mayo Clinic
Phoenix, AZ
05.2024 - Current
- Independently direct at least eight (8) complex Phase I-IV solid tumor clinical studies, streamlining regulatory workflows and ensuring strict adherence to institutional guidelines and evolving federal clinical trial laws while operating with high autonomy under minimal PI oversight.
- Partner with cross-functional research teams to conduct rigorous protocol feasibility assessments, identifying operational constraints and optimizing resource allocation to ensure successful study execution.
- Ensure implementation of seamless transition from IRB approval to study implementation, maintaining high standards of data integrity for mandatory continuing reviews and milestone-based reporting.
- Manage end-to-end participant lifecycle, from initial screening and informed consent to active monitoring, ensuring strict adherence to protocol timelines and GCP recruitment standards.
- Oversee the identification and expedited reporting of adverse or safety events, and protocol violations, maintaining full compliance with GCP safety reporting standards and institutional IRB requirements.
- Maintain high-quality clinical datasets by implementing rigorous internal monitoring and quality control (QC) workflows, resulting in zero major findings during monitoring visits.
- Provide education/training for other research staff within the department.
- Perform administrative and regulatory duties related to the study as appropriate.
- Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements.
- Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
- Participate in other protocol development activities and execute other assignments as warranted and assigned.
Clinical Research Coordinator II
Arizona Research & Rheumatology Research, PLC
Phoenix, AZ
11.2023 - 05.2024
- Managed multiple (10+) complex clinical trials on rheumatology and rare diseases, and oversees compliance to study protocols with ICH Good Clinical Practice Guidelines and FDA Regulations.
- Prepared and performed tasks required by protocol, which may include, but not limited to the following: 1. Obtaining informed consent, medical history, concomitant medications and vital signs. 2. Performing ECG, phlebotomy and other required study-related procedures. 3. Processing and shipping lab specimens for central and local labs. 4. Educating and training study participants. 5. Administering study-specific questionnaires and assisting with efficacy assessments. 6. Resolving queries and entering data into electronic system. 7. Handling study drug and completing investigational product accountability. 8. Maintaining accurate and up-to-date documentation and communication of all study activities. 9. Coordinating study visits and procedures with healthcare professionals and study participants. 10. Timely reporting of study events (adverse events, SAEs, protocol deviations) to appropriate departments, sponsors and outside agencies.
- Optimized CTMS workflows by overseeing essential documents and meticulously tracking subject status and visit metrics, facilitating accurate data reporting for Sponsor oversight and operational decision-making.
- Managed patient recruitment strategies, enhancing participant engagement in clinical studies.
- Oversaw high-volume IP accountability workflows, meticulously tracking the receipt, dispensing, and terminal reconciliation of study drugs and devices for multiple concurrent trials.
- Assisted in regulatory functions, including but not limited to preparing and filing appropriate Institutional Review Board (IRB) forms, updated informed consents, protocol continuations, protocol modifications, correspondence, adverse event and safety reports.
- Served as liaison to all physicians, company staff, regulatory personnel, clinical research organizations, sponsors and third-party vendors.
- Engaged in recurring study-specific and training sessions, collaborating with key stakeholders to maintain audit readiness and ensure cross-functional alignment on study milestones, enrollment targets, and protocol updates.
- Monitored patient safety profiles for assigned studies, implementing proactive risk mitigation strategies that ensured 100% compliance with safety reporting protocols and minimized subject risk.
Clinical Research Coordinator II
Voyage Medical
Tempe, AZ
08.2023 - 11.2023
- Maintained compliance with protocols during conduct of clinical trials, patient care and monitoring of clinical trial activities in compliance with ICH/GCP and FDA regulations.
- Coordinated and performed job tasks related to research participants including recruiting and screening potential study participants, determining participant eligibility, obtaining informed consent, scheduling study visits, overseeing study visits and acting as liaison between study participants and the research site.
- Managed high-volume laboratory specimen workflows, including processing and secure shipping to external reference labs, while maintaining full compliance with IATA/DOT regulations and OSHA biohazard safety standards.
- Facilitated end-to-end Site Initiation (SIV), Interim Monitoring (IMV), and Close-out Visits (COV), maintaining a 100% audit-ready environment
- Executed comprehensive safety monitoring and medical review for research participants, maintaining meticulous documentation of Adverse Events (AEs) and ensuring timely notification to IRBs, Sponsors, and regulatory authorities.
- Ensured regulatory requirements are met on research studies by maintaining and updating required regulatory documents.
- Optimized query resolution provided ongoing quality control audits and corrective action plans to maintain data integrity.
- Trained research assistants, assistant research coordinators, regulatory team and new clinical research site staff.
Lead Unblinded Clinical Research Coordinator
DM Clinical Research
Philadelphia, PA
11.2022 - 08.2023
- Maintained advanced proficiency in evolving FDA and ICH-GCP regulations, consistently executing study procedures in full alignment with global compliance standards and site-specific SOPs.
- Optimized Investigational Product (IP) management by redesigning IP storage workflows, enhancing temperature tracking accuracy and operational efficiency while maintaining strict compliance with clinical trial protocols.
- Maintained meticulous chain-of-custody records for clinical supplies, ensuring audit-ready documentation of IP lifecycle from initial shipment receipt to terminal destruction or return to sponsor.
- Facilitated routine site monitoring visits and regulatory audits with a 100% success rate, ensuring zero major findings in drug accountability and protocol compliance.
- Oversaw the site's Pharmacy Binder and drug accountability records, implementing standardized tracking for all clinical supplies and ensuring adherence to protocol requirements.
- Spearheaded the training and onboarding of new unblinded clinical staff, standardizing training workflows for drug accountability, IVRS/IWRS systems, and secure documentation management.
Medical Assistant
Mediversity Health
Turnersville, NJ
08.2022 - 11.2022
- Performed comprehensive clinical assessments including vital signs, evaluation of patient medical history and multi-drug regimens, to establish accurate baseline data.
- Assisted healthcare providers with routine checks and diagnostic testing by collecting and processing specimens.
- Completed appropriate clinical procedures and gathered patient data for interpretation by supervising physician.
- Enhanced patient compliance and safety by delivering specialized education on complex medication regimens and clinical procedures, ensuring a thorough understanding of standard of care plan.
- Demonstrated proficiency in performing administrative duties such as data entry, answering phones, ordering supplies, and managing patient records.
- Streamlined office procedures to improve patient flow and reduce wait times.
Home Health Occupational Therapist
Visiting Nurses Association Health Group
Howell, NJ
05.2019 - 05.2022
- Conducted comprehensive physical, cognitive and functional evaluations as well as home safety assessments to home-bound patients in two of the largest counties in New Jersey to identify their needs and devise customized rehabilitation plans to achieve patient's goals.
- Educated and instructed patients, family members and/or other patient representatives in rehabilitative care and activities necessary to promote patient's health, safety and independent living.
Director of Rehab/Lead Occupational Therapist
Tendertouch Rehabilitation Services
Lakewood, NJ
06.2013 - 06.2019
- Developed and implemented programs appropriate to needs of residents in facility to achieve highest feasible level of functioning.
- Liaised with patients, families and support departments to adequately plan for patient rehabilitation needs.
- Supervised, oriented, trained and counseled over 10 department employees to improve job performance and maintain high standards of patient care.
Travel Occupational Therapist
Atlas Rehabilitation, LLC
Birmingham, AL
10.2009 - 06.2013
- Performed evaluation and rehabilitative treatment for adult and geriatric patients in various skilled nursing and long-term care facilities in multiple states such as New Mexico, Texas, Missouri, Massachusetts and New Jersey.
- Collaborated with multidisciplinary teams to enhance patient care and optimize rehabilitation outcomes.
Medical Officer III
Adela Serra Ty Memorial Medical Center
05.2008 - 09.2009
- Optimized patient throughput by streamlining hospital admission and discharge protocols for adult and pediatric populations, significantly reducing wait times and improving bed turnover efficiency.
- Directed clinical management for a high-volume Pediatric Ward, providing diagnosis and evidence-based treatment for acute and chronic childhood illnesses while overseeing a multidisciplinary care team.
- Spearheaded the Newborn Screening Committee from September 2008 to August 2009.
Education
Doctor of Medicine -
Cebu Institute of Medicine
Cebu, PhilippinesBachelor of Science in Occupational Therapy -
Cebu Doctor's University
Mandaue, PhilippinesSkills
- Implementation of best clinical practices
- Dedicated work ethic
- Management of clinical trials
- Analytical reasoning
- Strong attention to detail
- Effective written communication
- Cross-functional teamwork
- Experience with multiple CTMS platforms
- Proficient in MS Office and Google applications
Affiliations
The Society of Clinical Research Associates, Inc (SOCRA)
Certification
- Certified Clinical Research Professional, May 2025
- Mayo Clinic Good Clinical Practice, May 2024
- Mayo Clinic IATA Certification, November 2023
- Basic Life Support, American Healthcare Academy, August 2025
- US Medical Licensing Exam Step 3 – Passed, August 2022
- Arizona Occupational Therapy Licensure, November 2023
- Commission for Foreign Medical Graduates Certification, April 2012
- Philippines Physician Licensure, March 2008
Timeline
Clinical Research Coordinator
Mayo Clinic
05.2024 - Current
Clinical Research Coordinator II
Arizona Research & Rheumatology Research, PLC
11.2023 - 05.2024
Clinical Research Coordinator II
Voyage Medical
08.2023 - 11.2023
Lead Unblinded Clinical Research Coordinator
DM Clinical Research
11.2022 - 08.2023
Medical Assistant
Mediversity Health
08.2022 - 11.2022
Home Health Occupational Therapist
Visiting Nurses Association Health Group
05.2019 - 05.2022
Director of Rehab/Lead Occupational Therapist
Tendertouch Rehabilitation Services
06.2013 - 06.2019
Travel Occupational Therapist
Atlas Rehabilitation, LLC
10.2009 - 06.2013
Medical Officer III
Adela Serra Ty Memorial Medical Center
05.2008 - 09.2009
Doctor of Medicine -
Cebu Institute of Medicine
Bachelor of Science in Occupational Therapy -
Cebu Doctor's University
CLINICAL RESEARCH EXPERIENCE
- VACCINE/IMMUNOLOGY
- A Randomized, Double-blind, Phase 3 trial to assess clinical efficacy, safety and reactogenicity of the recombinant MVA- BN RSV vaccine in adults ≥ 60 years of age
- A Phase 3, Randomized, Stratified, Observer-blind, Active controlled study to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1010 seasonal influenza vaccine in adults 18 years and older
- A Randomized, Observer-blind, Active-controlled Phase 3 study to investigate the safety, immunogenicity, and relative vaccine efficacy of mRNA-1283.222 administered as a booster dose compared with mRNA-1273.222 in participants aged 12 years and older for the prevention of COVID-19
- A Phase 1/2, Randomized, Observer-blind, Active-controlled, Dose-ranging study to evaluate the safety, reactogenicity and immunogenicity of mRNA-1468, a candidate vaccine to prevent Herpes Zoster (HZ) in healthy adults ≥ 50 years of age
- A Phase 1, Randomized, Observer-blind, Placebo-controlled, 2-part, dose-ranging study of an EBV candidate vaccine, mRNA-1195, in healthy adults 18 to 55 years of age
- A Phase 1, Randomized, Observer-blind, Active-controlled study to evaluate the safety, reactogenicity and immunogenicity of mRNA-based Influenza and SARS-CoV-2 multi-component vaccines in healthy adults
- A Phase 2/3, Randomized, Observer-blind, Placebo-controlled study to evaluate the safety and efficacy of mRNA-1345, an mRNA vaccine targeting respiratory syncytial virus (RSV), in adults ≥ 60 years of age
- A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
- CARDIOLOGY
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients with Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication
- NEUROLOGY
- A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of AR11001 over 52 Weeks in Participants with Early Alzheimer’s Disease
- ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer’s Disease Agitation
- ENDOCRINOLOGY
- A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adult Subjects and in Adult Subjects with Type 2 Diabetes Mellitus.
- RHEUMATOLOGY
- AbbVie M23-699: SELECT-SLE A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE
- AbbVie N23-700: A Phase 3b/4 Randomized, Double-blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
- AstraZeneca D3465C00001, A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus.
- Aurinia AUR-VCS-2021-03 Registry: A Prospective Observational Registry of Patients Treated with LUPKYNIS (Voclosporin) in the US
- Bendcare COVER: The CoVid19 Vaccine Response in Rheumatology Patients (COVER) study is a multicenter randomized controlled trial designed to evaluate the efficacy and safety of mRNA COVID-19 vaccine in patients with autoimmune conditions and to evaluate the impact of different immunomodulatory therapies on vaccine response
- BMS IM011-054: A Phase 3, Randomized, Doubleblind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
- Eli Lilly I4V-MC-JADJ: A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis
- Eli Lilly J1A-MC-KDAF: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis
- CoreVitas BIO-100 Biorepository: The Corrona Rheumatology Biorepository
- CoreVitas PsA/SpA-400: Spondyloarthritis and Psoriatic Arthritis (SpA/PsA) Registry
- CoreVitas RA-100: Rheumatoid Arthritis (RA) Registry
- Janssen CNT01959SPA40002 STAR: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants with Active Psoriatic Arthritis Axial Disease.
- LG Chem LG-GDCL010: A Randomized, Multiregional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients with Hyperuricemia
- MT Group (MTG) MTG-022: Study to evaluate biomarker/molecular characteristics in patients with autoimmune disease.
- SCIPHER-RA-003: Study to Accelerate Information of Molecular Signatures (AIMS) in Rheumatoid Arthritis
- Sun Pharma TILD-19-07: A Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1).
- Sun Pharma TILD-21-01: An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients with Psoriatic Arthritis
- Horizon HZNP-DAZ-301: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-severe Systemic Disease Activity
- ONCOLOGY (GENITO-URINARY, THORACIC and HEAD & NECK SOLID TUMOR CANCER)
- ADVANCED-2: A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
- A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)
- CAAA617C2301, PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
- Phase III Randomized Adjuvant Study of Pembrolizumab in MuScle InvaSive and LocAlly ADvanced UrOthelial CaRcInoma (AMBASSADOR) versus Observation
- Intra-patient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
- Positron Emission Tomography using 64Cu-SAR-bisPSMA in participants with high-risk prostate cancer prior to radical prostatectomy: A prospective, single-arm, multi-center, blinded-review, Phase 3 diagnostic performance study.
- A092001 Phase 2 Randomized Trial of Neoadjuvant or Palliative Chemotherapy with or without Immunotherapy for Peritoneal Mesothelioma (A092001)
- A phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma.