JENNY GARCIA
WESLEY CHAPEL,USA
Summary
Clinical Research Professional with 8+ years of experience supporting Phase I–IV clinical trials across oncology, gastroenterology, immunology, and rare/genetic diseases in both adult and pediatric populations. Experienced in site management, clinical operations, regulatory compliance, patient recruitment, data management, and cross-functional study coordination within global and multi-site clinical trial environments.
Demonstrated expertise in Good Clinical Practice (GCP), protocol compliance, risk-based monitoring support, CTMS/eTMF management, regulatory documentation, and site relationship management. Proven ability to support study startup, maintenance, closeout activities, and operational deliverables across North America and EMEA regions.
Certified Clinical Research Coordinator (ACRP) with experience supporting interventional, observational, randomized, double-blind, open-label, and long-term extension studies.
Overview
14
14
years of professional experience
1
1
Certification
Work History
ASSISTANT CLINICAL RESEARCH ASSOCIATE
THERMO FISHER SCIENTIFIC
WILMINGTON, NC
09.2022 - Current
- Responsible for managing all in-house site operations in compliance with Good Clinical Practices (GCP). Conduct regular site management calls to ensure that study sites are meeting their responsibilities and maintaining adherence to protocols. Document any issues that arise during these interactions and work to resolve them, escalating any deficiencies or concerns to management promptly and in line with the study's communication and monitoring plan. Serve as the primary point of contact for study sites, address ad-hoc requests and assist in resolving outstanding data queries. Provide ongoing site training, ensuring study systems are updated according to agreed conventions, facilitating effective communication between the project team and sponsor.
- Coordinated clinical trial activities, ensuring compliance with regulatory standards to support successful study execution.
- Conducted site visits to evaluate protocol adherence and data integrity, contributing to data quality and study reliability.
- Monitored patient recruitment and retention efforts, enhancing participant engagement and study continuity.
CLINICAL RESEARCH COORDINATOR II
MOFFIT CANCER CENTER
TAMPA, FL
10.2021 - 09.2022
- Contributed to various Phase I-II clinical trials in oncology, including studies focused on Ovarian Cancer, Non-Small Cell Lung Cancer, and Sarcoma, in adult subjects. Responsibilities encompassed overseeing the entire site study lifecycle, from feasibility assessments and startup to study maintenance, closeout, and archiving. Managed the informed consent process and participated in regular management calls to ensure study compliance and progress.
- Coordinated clinical trial activities across multidisciplinary teams, ensuring seamless collaboration and adherence to study timelines.
- Managed patient recruitment processes to enhance diversity and eligibility of study populations, contributing to robust trial outcomes.
- Developed and maintained study documentation, ensuring compliance with regulatory standards and facilitating successful audits.
CLINICAL RESEARCH ASSISTANT
CANCER PREVENTION PHARMACEUTICALS, INC
TUCSON, AZ
02.2014 - 04.2016
- Supported VP of Clinical Operations and North American and European site CRAs and study site staff on 7 phase I-III clinical trials in hematology/oncology and digestive system, overseeing study supply inventory, coordinating site supply shipments, maintaining sponsor master files, and assisting in regulatory submissions to FDA.
- Coordinated clinical trial activities, ensuring adherence to regulatory standards and contributing to successful trial execution.
- Assisted in the preparation of study protocols and informed consent documents.
- Managed patient recruitment processes for various clinical studies, enhancing participant engagement and enrollment efficiency.
CLINICAL RESEARCH COORDINATOR
ADOBE CLINICAL RESEARCH, LLC
TUCSON, AZ
08.2012 - 10.2013
- Led 20+ North American Phase I-IV clinical trials as Site Lead/Primary Clinical Research Coordinator, ensuring adherence to protocols and regulatory requirements across diverse study designs.
- Coordinated clinical trials to ensure compliance with regulatory standards and protocols.
- Managed patient recruitment and enrollment processes for various research studies.
- Developed and maintained study documentation and regulatory binders for audits.
Education
Associate of Applied Science - Tucson, Arizona, USA
Pima Community College
Tucson, Arizona, USA05.2013
Skills
- Clinical trial management
- Clinical data management
- Data integrity monitoring
- Regulatory compliance
- Good clinical practices and ICH guidelines
- Protocol adherence
- Patient recruitment strategies
- Team leadership
- Attention to detail
Affiliations
- Association of Clinical Research Professionals, September 2018
Certification
ACRP Certified Clinical Research Coordinator, 2018-01-01
Regulatory Experience And Expertise - Regulatory Authorities
- Belgium
- Germany
- The Netherlands
- Spain
- United Kingdom
- North America
Therapeutic Experience And Expertise
Crohn's Disease, Irritable Bowel Syndrome, Constipation, Diarrhea, Polyposis, Plaque Psoriasis, Hereditary angioedema, Eosinophilic esophagitis, Clostridioides difficile, Colon Cancer, Gastrointestinal Cancer, Colorectal Cancer, Sarcoma, Ovarian, Non-small Cell Lung, Familial Adenomatous Polyposis
Additional Relevant Experience
- Key Risk Indicator
- Risk Based Analysis
- Investigator Meeting planning
- Community Outreach for Recruitment
- Computer Experience
- Microsoft Office (Word, Excel, PowerPoint)
- EDC (iMedidata, Medidata RAVE, eClinicalOS, Oracle (InForm), imednet, Redcap, ClinCapture, ERT, BioClinica, Banook, Ness (eSource and EDC), Endpoint)
- ETMF
Languages
- Spanish
- English, Native
- Spanish, Proficient
Timeline
ASSISTANT CLINICAL RESEARCH ASSOCIATE
THERMO FISHER SCIENTIFIC
09.2022 - Current
CLINICAL RESEARCH COORDINATOR II
MOFFIT CANCER CENTER
10.2021 - 09.2022
CLINICAL RESEARCH ASSISTANT
CANCER PREVENTION PHARMACEUTICALS, INC
02.2014 - 04.2016
CLINICAL RESEARCH COORDINATOR
ADOBE CLINICAL RESEARCH, LLC
08.2012 - 10.2013
Associate of Applied Science - Tucson, Arizona, USA
Pima Community College