GARIBA GARVEY
Greenwich,CT
Summary
Result-driven Clinical Research Associate with over5 years of expertise in overseeing global and national studies across various Therapeutic Areas, Respiratory, CNS Neurology, Gastroenterology, Cardiovascular, and Oncology. Monitoring experience encompasses pediatric and adult populations, covering diverse aspects such as site selection, protocol adherence, standard operating procedures, good clinical practice, and regulatory requirements. I have conducted Pre-Study Visits, Site Initiation Visits, Monitoring Visits, and Close-out Visits. As a motivated CRA, I possess robust organizational, documentation, presentation, and interpersonal skills. My experience includes 3 years of site management and monitoring clinical trials, overseeing global studies (Phases I – III) from inception through maintenance and closure phases. I thoroughly understand ICH-GCP guidelines and have undergone internal and sponsor audits, showcasing strong leadership and interpersonal abilities.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Apex Medical Research
01.2022 - Current
- Conducted clinical trials monitoring, site management, and data review to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements
- Managed and tracked site performance metrics, adverse events, and concomitant medications to ensure accurate and timely reporting
- Reviewed and verified clinical data listings for completeness and accuracy, escalating issues to senior management as needed reports by the protocol
- Maintained accurate and up-to-date records of clinical trial activities, including site visits, data review, and correspondence
- Collaborated with cross-functional teams, including clinical affairs, to develop and implement clinical trials databases and Electronic Data Capture (EDC) systems
- Coordinated with investigative sites to resolve queries, address concerns, and provide training on clinical trials procedures
- Developed and delivered presentations to senior management, Lead CRAs, PIs, and team members to brief on study progress and results
- Conducted on-site monitoring visits, including pre-study, initiation, interim, and close-out visits to ensure compliance with protocols and regulations
- Collaborated with clinical affairs to develop and implement clinical trials protocols, informed consent forms, and case report forms
- Participated in team meetings and teleconferences to share information, discuss study progress, and address book challenges
Clinical Research Associate
SPRI UKRAINE
08.2020 - 07.2021
- Managed and monitored Phase II and III clinical trials to ensure compliance with protocol, regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOPs)
- Conducted pre-study, initiation, interim, and close-out site visits, including site qualification, initiation, monitoring, and close-out activities
- Reviewed and verified clinical trial data, source documentation, and case report forms (CRFs) for accuracy, completeness, and adherence to protocol
- Developed and maintained positive relationships with investigators, site staff, and study sponsors to facilitate study conduct and resolution of study-related issues
- Coordinated and conducted investigator meetings, study training, and site initiation visits to ensure site staff's understanding of study protocols and procedures
- Assisted in training Interns and creation of job aids
- Prepared, Reviewed, and submitted regulatory documents, including Institutional Review Board (IRB) submissions, amendments, and safety reports, in compliance with regulatory requirements and timelines
- Implemented risk-based monitoring strategies to identify and mitigate risks to data quality and patient safety
- Collaborated with internal cross-functional teams (i.e., Clinical Science, Biometrics, Regulatory Affairs, etc.), to ensure effective delivery of the assigned project milestones
Clinical Research Coordinator
Kharkiv Children Hospital #19
05.2018 - 06.2020
- Assisted in the coordination and management of clinical trials, including patient recruitment, screening, and enrollment
- Maintained study documentation and regulatory files, ensuring compliance with regulatory requirements and internal procedures
- Conducted site monitoring visits under the supervision of a Clinical Research Associate, ensuring protocol compliance and data accuracy
- Prepared and distributed study-related materials, including informed consent forms, study binders, and study drug shipments
- Coordinated with external vendors and laboratories to ensure subject samples are sent and research supplies are available
- Assisted in preparing study protocols, case report forms (CRFs), and clinical study reports
Education
Bachelors in Medicine -
Kharkiv National Medical University
Kharkiv UkraineSkills
- Excellent communication and interpersonal skills
- Proficient in Microsoft Office Suite, RegDocs, electronic data capture (EDC) Systems, Clinical Trial Management (CTMS), Electronic Document Management Systems (EDMS), ETMG - Veeva Vault, IWRS-Bracket & Bioclinica
- Detail-oriented with strong organizational and time management skills
- Ability to work independently and collaboratively in a fast-paced environment
- Source document verification
- Experience with Research Protocols and regulatory bodies (HIPAA, FDA, IRB)
- IRB submissions
- Serious Adverse Event Reporting(SAE), Narratives, and follow-up of SAEs
- Through knowledge of ICH Guidelines and an understanding of local regulatory requirements
- Informed consent process
- MS Word, Outlook, Excel, PowerPoint, Access & One Note
- Site monitoring
Certification
- Clinical Trial Operations: John Hopkins University
- University Of California San Diego: Drug Development Product Management.
- Good Clinical Practice Certification
- Basic Life Support
- Certified Clinical Research Associate (CCRA) (expected June2025)
Accomplishments
- Successfully managed a Phase III clinical trial for an investigational immunotherapy in melanoma patients, ensuring timely completion and high-quality data.
- Led a biomarker study to predict response to targeted therapy in lung cancer patients, identifying key markers that informed future treatment strategies for Ulcerative Colitis.
- Coordinated a multicenter study assessing CAR-T cell therapy in patients with relapsed/refractory acute lymphoblastic leukemia Monitoring in Immuno-Oncology Clinical Trial.
- Contributed to a trial evaluating the safety and efficacy of a transcatheter aortic valve replacement (TAVR) system in patients with severe aortic stenosis. Phase II & III.
Timeline
Clinical Research Associate
Apex Medical Research
01.2022 - Current
Clinical Research Associate
SPRI UKRAINE
08.2020 - 07.2021
Clinical Research Coordinator
Kharkiv Children Hospital #19
05.2018 - 06.2020
Bachelors in Medicine -
Kharkiv National Medical University
Similar Profiles
Reagan RitchieReagan Ritchie
Inorganic Metals Intern at APEX ResearchInorganic Metals Intern at APEX Research
Samundeeswari DSamundeeswari D
Biodegradation of poly aromatic hydrocarbon by using bacteria at Apex biotechnology training and research instituteBiodegradation of poly aromatic hydrocarbon by using bacteria at Apex biotechnology training and research institute
Dharani PalojuDharani Paloju
Intern at Apex Biotech Training and Research InstituteIntern at Apex Biotech Training and Research Institute
Alexis BatistaAlexis Batista
Babysitter at Family MembersBabysitter at Family Members
Nicolette DeVitoNicolette DeVito
Behavior Technician Therapist at Achieve Beyond Pediatric Therapy & Autism ServicesBehavior Technician Therapist at Achieve Beyond Pediatric Therapy & Autism Services