Veronica Marin
Grayslake,IL
Summary
With 8 years in clinical research, including 4 years in the Contract Research Organization (CRO) sector and an additional 4 years in related roles, I bring proven expertise in leading clinical operations, managing budgets and timelines, and ensuring compliance with ICH/GCP and global regulations. My experience encompasses leading cross-functional teams, managing external stakeholders, and driving study milestones. Renowned for my growth mindset, innovative problem-solving abilities, and patient-centric approach, I am well-equipped to excel in the Line Manager role at Icon and contribute effectively to your team.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate (Sr CRA I)
Syneos Health
07.2023 - Current
- Groomed by the Clinical Trial Manager to spearhead project activities for Clinical Research Associates ensuring alignment with overall program strategy while managing risks, budget, effort estimates, and schedules.
- Serve as the main liaison for 22 clinical research sites and functional team members for assigned clinical trials, ensuring clear communication and effective collaboration.
- Groomed by the Clinical Trial Manager to collaborate with the Business Development team to prepare and present bid defenses, demonstrating the project's value and strategic fit.
- Oversee activities across multiple functions to achieve program objectives related to scope, budget, and schedule.
- Create and implement risk mitigation plans, including communication and escalation strategies to address and reduce potential issues.
- Proactively identify and implement solutions to enhance existing business processes and increase efficiency.
- Assisted the Clinical Trial Manager to manage project finances in accordance with customer contracts and budgets; coordinate with the Director of Finance, RWE Clinical Trials for financial oversight.
Senior Site Manager
Kelly Science, Engineering, Technology & Telecom
12.2021 - 12.2022
- Managed site qualification and performance, ensuring that facilities met study protocol requirements and regulatory standards.
- Conducted thorough evaluations of investigator sites, including the assessment of qualifications, facilities, equipment, and overall performance.
- Trained and mentored site staff on study protocols and operational procedures during site initiation visits, ensuring a strong foundation for study execution.
- Expertly handled quality reporting and problem resolution, leveraging strong organizational and research skills to address and resolve issues efficiently.
- Reviewed and ensured accuracy of site drug accountability logs, maintaining precise documentation for each patient.
- Implemented effective query resolution techniques both remotely and on-site, guiding site staff to address and close queries within agreed timelines.
- Monitored key study performance indicators, assessing site performance metrics and creating and executing action plans for sites falling short of expectations.
Senior Clinical Research Associate (Sr CRA I)
IQVIA
12.2020 - 12.2021
- Provided 1:1 mentoring to junior CRAs and led remote site initiation and monitoring visits during the COVID-19 pandemic, adapting to and adhering to new remote monitoring protocols.
- Developed and spearheaded the Mentor Leaders’ Program, enhancing team skills and leadership capabilities within the organization.
- Participated in global conference calls and meetings, reviewing and discussing the progress of ongoing clinical trials to ensure alignment with study objectives.
- Managed multiple responsibilities simultaneously, maintaining meticulous attention to detail and quality across all tasks.
- Verified compliance with approved protocols and GCP procedures, ensuring that investigators adhered to study requirements and regulatory standards.
Clinical Research Associate (CRA II)
IQVIA
09.2020 - 11.2020
- Maintained adherence to procedures, practices, and regulatory requirements, ensuring health, safety, and environmental compliance throughout study execution.
- Resolved data discrepancies by reviewing data queries and listings, collaborating with study centers to ensure accurate and consistent data.
- Verified the accuracy and completeness of clinical data, source documentation, case report forms, and investigative site regulatory files, ensuring compliance and reliability of study records.
Clinical Research Associate (CRA)
IQVIA
01.2019 - 08.2019
- Completed a comprehensive 12-week CRA onboarding program, gaining in-depth knowledge of clinical trial processes and regulatory standards.
- Conducted initiation, monitoring, and closeout visits to ensure rigorous adherence to study procedures, regulatory requirements, and data accuracy.
- Reviewed participant eligibility and consent documentation, supporting researchers in achieving precise and meaningful study results.
Certified Clinical Research Coordinator
Uptown Research Institute
12.2015 - 01.2019
- Managed over 10 research protocols effectively in collaboration with investigators, vendors, multidisciplinary teams, and protocol sponsors, ensuring successful project execution.
- Evaluated, monitored, and coordinated patient participation in clinical trials, facilitating smooth recruitment and adherence to study protocols.
- Applied Good Clinical Practice (GCP), FDA, ICH, and CFR guidelines to ensure ethical and standard conduct of clinical trials, upholding the highest regulatory and procedural standards.
- Demonstrated expertise in startup and closeout paperwork at the site level, ensuring all documentation was accurate and compliant with regulatory requirements.
- Supported the Chief Operating Officer with daily operational functions, contributing to the efficient management of site operations and administrative tasks.
- Developed and maintained an effective inpatient environment for both patients and staff involved in inpatient studies, enhancing study conditions and participant experience.
- Trained and supervised regulatory coordinators, recruitment coordinators, and entry-level staff, ensuring adherence to study protocols and high-quality performance.
- Administered specialized assessment scales including the Columbia-Suicide Severity Rating Scale (C-SSRS), Epworth Sleepiness Scale (ESS), Modified Medication Satisfaction Questionnaire (MSQ), and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) with precision and care.
- Collaborated with a sponsor auditor during a 482 FDA visit, maintaining effective communication with medical monitors and clinical research associates to address audit findings and ensure compliance.
- Oversaw pharmaceutical responsibilities, including DEA222 submissions and drug returns, ensuring accurate and timely handling of investigational products.
- Managed documentation for subject accountability and Investigational Product (IP) compliance, ensuring meticulous record-keeping and adherence to study requirements.
- Expertly maintained Trial Master Files (TMF), ensuring all study documentation was complete, accurate, and readily accessible for audits and inspections.
- Certified in Bloodborne Pathogens for Clinical or Research Lab Workers and trained as a phlebotomist, demonstrating a commitment to safety and proficiency in clinical procedures.
Research Coordinator
Northwestern University
08.2014 - 12.2015
- Implemented and documented Standard Operating Procedures (SOPs) in alignment with study sponsor, primary investigator, and regulatory agency requirements, ensuring compliance and consistency across clinical trials.
- Managed all aspects of clinical trial conduct, including screening, enrollment, patient visits, subject follow-up, and completion of case report forms and adverse event reports, ensuring comprehensive and accurate execution.
- Maintained effective communication and workflow, ensuring that study goals and objectives were met and addressing any issues promptly to keep the study on track.
- Handled study finances and petty cash distribution, ensuring proper financial management and accurate allocation of resources for participant reimbursement.
- Utilized MRI safety training from The Center for Translational Imaging to assist research participants in fMRI and MRI scans, ensuring safe and effective participation in imaging studies.
- Evaluated and ensured adherence to Institutional Review Board (IRB) guidelines for study protocols and participant involvement, upholding ethical standards and regulatory compliance.
- Administered psychological interviews and computerized cognitive tests, providing detailed assessments to research participants and contributing to study data.
- Trained in the administration of various assessment scales, including the Structured Clinical Interview for DSM-IV-TR-Axis I Disorders (SCID), Mini International Neuropsychiatric Interview (MINI), Wechsler Abbreviated Scale of Intelligence (WASI), and Wide Range Achievement Test (WRAT), demonstrating proficiency in conducting psychological evaluations.
Education
Bachelor of Psychology -
University of Illinois At Chicago
01.2013
Skills
- Clinical Study Design & Execution
- Budget Management & Oversight
- Cross-Functional Team Leadership
- Vendor & Stakeholder Management
- Risk Identification & Mitigation
- Growth Mindset & Continuous Learning
- Effective Communication & Problem Solving
- Compliance with ICH/GCP and Global Regulations
- Completing regulatory documents
- Action planning
- Site Management
Certification
- Certified Clinical Research Coordinator (CCRC)
- Bloodborne Pathogens for Clinical or Research Lab Workers Certified
- Trained Phlebotomist
Additional Information
Ability to sit for prolonged periods as required by job duties.
Publications
Keypress-Based Musical Preference Is Both Individual and Lawful, Livengood, S. L., Sheppard, J. P., Kim, B. W., Malthous, E. C., Bourne, J. E., Barlow, A. E., Lee, M. J., Marin, V., O'Connor, K. P., Csemansky, J. G., Block, M. P., Blood, A. J., Breiter, H. C., Frontiers in Neuroscience, 11, 136, 2017
Timeline
Senior Clinical Research Associate (Sr CRA I)
Syneos Health
07.2023 - Current
Senior Site Manager
Kelly Science, Engineering, Technology & Telecom
12.2021 - 12.2022
Senior Clinical Research Associate (Sr CRA I)
IQVIA
12.2020 - 12.2021
Clinical Research Associate (CRA II)
IQVIA
09.2020 - 11.2020
Clinical Research Associate (CRA)
IQVIA
01.2019 - 08.2019
Certified Clinical Research Coordinator
Uptown Research Institute
12.2015 - 01.2019
Research Coordinator
Northwestern University
08.2014 - 12.2015
Bachelor of Psychology -
University of Illinois At Chicago
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