ROSEMARIE ABARY
Clinical Research Professional
Glendora,California
Summary
Skilled Research Professional with extensive industry-sponsored clinical research experience across a range of therapeutic areas including multiple oncology indications. Is well-versed in Good Clinical Practices, the clinical and operational aspects of trial execution, regulatory requirements, adverse event reporting, MedDRA terminology, data collection conventions, data reporting, and audit readiness. Has reputation for being detail-oriented and thorough while remaining focused on how data relates to trial endpoints. Will leverage clinical acumen, trial execution experience, understanding of trial objectives to contribute to the success of clinical development programs as a clinical scientist.
Overview
15
15
years of professional experience
4015
4015
years of post-secondary education
1
1
Certification
Work History
Senior Clinical Research Associate
Catalyst Clinical Research, LLC.
04.2023 - Current
- Monitor clinical trials according to monitoring plans to achieve project goals; conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs, and complete visit related documentation within specified company timeline
- Manage regulatory authority applications and approvals, obtaining regulatory documentation for successful implementation, monitoring and evaluation of clinical trials, where necessary
- Work with the study start up team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
- Assist site staff in driving patient recruitment and develop enrollment plans in conjunction with site staff
- Perform data review activities, collaborate with data management to identify trends and implement corrective action to enhance data quality
- Ensure study documentation is maintained in the Investigator Study File and where necessary ensure relevant documents are transferred or copied to the (electronic) Trial Master File
- Document accountability, stability and storage conditions of clinical trial materials as required by the sponsor
- Perform investigational product inventory and ensure return of unused materials to designated location/verify destruction as required
- Effectively communicate with site study staff and Catalyst Clinical Research LLC
- Clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study related issues
- Pro-actively manage site issues and incorporate a root cause analysis and corrective action and preventive action plan
- Coordinate with the ethics committee in order to ensure the rights, safety and well-being of all trial subjects including provision of updates according to local requirements
- Participate in project audit/inspection preparation and conduct, as necessary, and assist with audit/inspection responses
- Collaborate closely with the Project Manager and Clinical Trial Lead
- Work closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor, and other trial staff
- Maintain a home office if working remotely
- Manage work activities in a time- and cost-effective manner to ensure budgetary guidelines and project timelines are met
- Participate in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines
- May provide training including but not limited to co-monitoring for new monitors regardless of their previous monitoring experience
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Facilitated clear communication across study teams, ensuring timely updates on project progress and proactively addressing potential issues.
Consultant/Senior Clinical Research Associate
ABARY CONSULTING
08.2022 - Current
- Responsible for overseeing the preparation and execution of complex oncology trials in the field with the aim of insuring data integrity and patient safety
- Involved in recruitment of investigators, evaluation of site capabilities, site initiation activities, and assessment of compliance with study execution
- Possesses expert knowledge of study protocols
- Reviews medical records, laboratory data, radiologic reports, ECGs, and other safety data against reported clinical data to ensure adherence to eligibility criteria and adverse event reporting requirements
Senior Clinical Research Associate
IQVIA
12.2018 - 09.2022
- Responsible for overseeing the preparation and execution of complex oncology trials in the field with the aim of insuring data integrity and patient safety
- Involved in recruitment of investigators, evaluation of site capabilities, site initiation activities, and assessment of compliance with study execution
- Possesses expert knowledge of study protocols
- Reviews medical records, laboratory data, radiologic reports, ECGs, and other safety data against reported clinical data to ensure adherence to eligibility criteria and adverse event reporting requirements
- Accomplishments have included:
- Actively managing 5-7 protocols in 5 indications at 10-12 sites
- Uses excellent organizational and communication skills to monitor study progress and proactively address site issues
- Has mastered use of multiple EMR systems to efficiently review data and check medical logic of data reporting
- Has developed a reputation for astute medical observations in data review; was commended for identifying findings missed by other reviewers
- Actions averted unfavorable inspection findings and allowed team to enact timely corrective actions
- Demonstrates ability to prioritize tasks and work effectively under high time pressure while maintaining high quality standard
Sub-Investigator / Clinical Research Associate II
City of Hope
03.2018 - 12.2018
- Gained broad experience in the conduct of industry-sponsored and investigator-initiated oncology trials in the areas of leukemia and lymphoma
- As a CRA II, was responsible for maintaining data integrity and regulatory compliance for a portfolio of 40+ trials
- Abstracted data, completed CRFs, reported adverse events, and responded to data queries
- Maintained data in audit ready state, ensured compliance with all IRB and regulatory filing, was responsible for project budgets and billing
- When promoted to Sub-Investigator role, responsibilities shifted toward supporting clinical assessments of efficacy and safety
- Accomplishments included:
- Acquired deep understanding for phase 1-4 oncology clinical development protocols
- Has experience assessing patients for trial eligibility, reviewing medical records, previous treatment regimens, imaging and pathology reports
- Understands which assessments are critical to efficacy assessments and ensures study procedures, specimen collections, and other data collection are accomplished per protocol
- Performed thorough source documentation and careful data collection and entry
- Became skilled in reviewing laboratory data and other safety assessments for purposes of safety reporting
- Proficient in using the conventions of CTCAE
- Collaborated with Principal Investigators to ensure all safety reporting completed according to protocol requirements within regulatory timelines
- Produced accurate data summaries for internal and external trial collaborators
- Organized and conducted periodic interdisciplinary project team meetings to review new trials and chart progress of ongoing trials
- Contributed to academic publications and presentations including peer reviewed manuscripts, tumor boards, and Grand Rounds
- Has taken the initiative in creating power point slides to be presented to other clinicians and clinical research staff reflecting pertinent information from the study protocol for site initiation or training visits
Clinical Research Coordinator/HIV Counselor/Community Liaison
UCLA Clinic to Help Everyone Clinic
09.2016 - 01.2017
- Served as clinical research coordinator for pre- and post-exposure prophylaxis (Pre-EP and PEP) HIV clinical trials
- Recruited patients through a community outreach program of speaking engagements
- Performed delegated trial duties including obtaining informed consent, screening patients for eligibility, and performing other study assessments
- Was responsible for all data entry and query resolution
- Additional duties included providing appropriate HIV counseling to all patients undergoing testing
- Skills and accomplishments included:
- Demonstrated excellent public speaking skills during community presentations
- Was able to adjust presentations to fit the audiences' needs, interests, and knowledge levels
- Had reputation for using broad skill set on the job to accomplish study tasks efficiently
Clinical Research Coordinator
LA Clinical Trials
01.2015 - 05.2016
- Served as the lead clinical research coordinator for an industry-sponsored smoking cessation study
- Worked collaboratively with the Principal Investigator to execute the study in accordance with the protocol and GCP guidelines
- Was responsible for recruiting patients, assessing eligibility, educating patients on study requirements, data collection, and adverse event reporting
- Accomplishments included:
- Participated in site quality assurance measures including activities related to monitoring medication safety, drug accountability, and ensuring proper safety reporting
Clinical Research Site Manager
04.2010 - 12.2012
Education
Master of Science - Nursing Leadership And Management
American University of Health Sciences
Long Beach, CA 05.2023 - 12.2025
M.D. - Rotating Clinical Internship
Our Lady of Fatima Medical Center
Valenzuela, Philippines 05.2005 - 01.2007
Doctor of Medicine -
University of Our Lady of Fatima School of Medicine
Valenzuela, PhilippinesBachelor of Arts - Psychology
University of California, Riverside
Riverside, CABachelor of Science - Nursing
St. Dominic Savio College
Manila, Philippines 09.2019 - 05.2023
Skills
Clinical trial management
Certification
RN, Montana, 219400
Publications
A Multi-center phase II trial of bortezomib and rituximab maintenance combination therapy in patients with mantle cell lymphoma after consolidative autologous stem cell transplantation., Chen, R. W., Palmer, J. M., Tomassetti, S., Popplewell, L. L., Alluin, J., Chomchan, P., Nademanee, A. P., Siddiqi, T., Tsai, N. C., Chen, L., Zuo, F., Abary, R., Cai, J. L., Herrera, A. F., Rossi, J. J., Rosen, S. T., Forman, S. J., Kwak, L. W., Holmberg, L., J Hematol Oncol., 2018, 11, 1, 87
Therapeuticexperience
- Oncology: Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Small lymphocytic lymphoma, Cutaneous T-cell lymphoma, Peripheral T-cell lymphoma, Mantel Cell lymphoma, Breast cancer, Prostate cancer, Pancreatic Cancer, Colorectal Cancer, Sarcoma, Gastric Cancer, Ovarian Cancer
- Infectious Disease: HIV, Preexposure HIV prophylaxis, Postexposure HIV prophylaxis, Influenza, Aspergillosis
- Immunology: Peanut allergy
- Gastroenterology: Celiac disease, Primary biliary cholangitis
- Endocrine and Metabolism: Type 2 diabetes mellitus, Type 1 diabetes mellitus
- Renal: Chronic kidney disease, Anemia associated with chronic kidney disease
- Women's Health: Uterine fibroids
- Addiction: Tobacco Use
- Neurology: Alzheimer's disease
Timeline
Master of Science - Nursing Leadership And Management
American University of Health Sciences
05.2023 - 12.2025
Senior Clinical Research Associate
Catalyst Clinical Research, LLC.
04.2023 - Current
Consultant/Senior Clinical Research Associate
ABARY CONSULTING
08.2022 - Current
Bachelor of Science - Nursing
St. Dominic Savio College
09.2019 - 05.2023
Senior Clinical Research Associate
IQVIA
12.2018 - 09.2022
Sub-Investigator / Clinical Research Associate II
City of Hope
03.2018 - 12.2018
Clinical Research Coordinator/HIV Counselor/Community Liaison
UCLA Clinic to Help Everyone Clinic
09.2016 - 01.2017
Clinical Research Coordinator
LA Clinical Trials
01.2015 - 05.2016
Clinical Research Site Manager
04.2010 - 12.2012
M.D. - Rotating Clinical Internship
Our Lady of Fatima Medical Center
05.2005 - 01.2007
RN, Montana, 219400
Doctor of Medicine -
University of Our Lady of Fatima School of Medicine
Bachelor of Arts - Psychology
University of California, Riverside
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