Clinical Research Project Management

Marina R. Fishbein

Clinical Research Associate

ad5xlu@r.postjobfree.com ● 443-***-****

LinkedIn ● Washington, DC Metropolitan Area

Meticulous, highly analytical, and detail-oriented professional with a comprehensive background in managing clinical trial processes across various stages of drug development. Adept in facilitating scientific discussions, maintaining investigator relationships, and ensuring protocol adherence and ICH-GCP compliance. Skilled in site management, data integrity, and protocol compliance across various therapeutic areas. Instrumental in leveraging extensive experience in electronic data capture and regulatory compliance to ensure robust study execution and data integrity. Proven ability to facilitate effective collaboration among clinical sites, sponsors, and CROs to drive successful trial outcomes. Track record of facilitating clinical research projects, preparing, and presenting comprehensive reports, and driving clinical excellence.

Areas of Expertise:

Clinical Trial Management

Regulatory Compliance & Auditing

Site Management & Monitoring

Protocol Development & Review

Data Integrity & Analysis

GCP & ICH Guidelines Compliance

Safety Reporting & SAE Management

Cross-Functional Team Leadership

Problem Solving & Decision Making

Electronic Data Capture Systems

Pharmaceutical Research

Quality Control & Assurance

Public Health & Epidemiology

Clinical Operations Optimization

Budget Management & Cost Control

Professional Experience

Independent Occupational Care – Baltimore, MD

Care Provider and Family Member (Unpaid)

2023 – 2024

Provided comprehensive daily care and support to a family member experiencing significant health issues. Managed medication schedules, coordinated medical appointments, and ensured adherence to treatment plans. Implemented daily routines to improve quality of life. Maintained open communication with healthcare professionals to monitor progress and adjust care plans as necessary.

Premier Research International, LLC – Remote/Northeast Region

Clinical Research Associate

2022 – 2023

Developed and delivered monitoring reports within required timelines to secure sponsor approval according to clinical monitoring plan. Managed on-site qualification, study initiation, interim monitoring, and close-out visits. Kept accurate project tracking systems for subjects and site information. Conducted comprehensive reviews of investigational product accountability and related logs as specified in clinical monitoring plan. Oversaw comprehensive remote and onsite monitoring activities and assured data integrity, patient safety, and compliance with specific country regulations.

Ensured validity, accuracy, and integrity of clinical data at assigned sites, while adhering strictly to ICH GCP/ISO14155, protocol, and client requirements.

Maintained and updated Trial Master File (TMF)/electronic Trial Master File (eTMF) in compliance with organizational processes and ICH/GCP Section 8 requirements.

Established and sustained consistent and documented communications with study sites according to clinical monitoring plan.

Assured seamless execution and successful delivery of projects within defined quality, scope, timeline, and budget parameters.

Completed all mandatory internal training (general and study-specific) on time and served as a mentor and resource for other Clinical Research Associates.

Proficiently deployed leading eTMF systems including Trial Interactive, Rave eTMF, and Veeva Vault, and managed project data using Smartsheet and Microsoft Office.

Supernus Pharmaceuticals – Rockville, MD

In-House Clinical Research Associate

2021 – 2022

Administered document collection, data review from Electronic Data Capture (EDC), and verification of data accuracy with source documents. Resolved clinical queries across various electronic databases. Collaborated with management to uphold compliance with standard protocols, regulatory, and GCP requirements during clinical site monitoring.

Ensured remote clinical monitoring and site management aligned with Standard Operating Procedures (SOPs) and International Conference on Harmonisation’s guidelines for Good Clinical Practice (GCP).

Addressed and escalated site quality, performance, and safety issues; communicated findings to project management team in detailed trial status reports.

Supported site recruitment activities as needed, using phone scripts, questionnaires, and study materials to assess investigative sites; ensured sites remained audit-ready by overseeing regulatory document management.

Delivered proactive support to site staff in adhering to trial protocols to prioritize participant protection and safety.

Johns Hopkins University School of Medicine – Baltimore, MD

Study Coordinator Apprentice

2020 – 2021

Facilitated effective communication and correspondence as primary contact with study participants, various departments, CROs, and sponsors. Collaborated with principal investigator and study team to develop, amend, and execute protocols. Interpreted scientific protocols and prepared comprehensive study reports and materials. Prepared and submitted protocols for IRB application, while maintaining and updating IRB documentation meticulously. Performed accurate data entry and resolved queries in eCRFs using EDC systems, including Oracle/InForm, Medidata/Rave, and REDcap. Collected, processed, packaged, labeled, and shipped blood samples to ensure quality and compliance.

Conducted prescreening of patient participants by comparing inclusion/exclusion criteria, introducing, and consenting study participants, and assisting them through scheduled visits as per protocols.

Engaged in site initiation visits, remote monitoring visits, and close-out visits to ensure protocol adherence and study progression.

Maintained certifications and knowledge in Good Clinical Practice, Human Subjects Research, IATA, and ICH requirements.

Completed advanced courses and lectures in research coordination through Johns Hopkins University.

Trained in Clinical Rotation Units, practicing phlebotomy skills, and determining vital statistics, such as height, weight, pulse, temperature, blood pressure, respiratory rate, and 12-lead ECG, and.

Protected against bio-hazardous materials, including blood-borne pathogens by implementing universal safety precautions.

The Marini Home Private Care – Damascus, MD

Respite Care Provider

2019

Delivered part-time care for a 12-year-old boy on life-support, ensuring his safety and comfort. Administered medications and fluids via G-tube, maintained sterility of trach/G-tube openings and ports, and managed diaper changes and catheterization for fluid retention, while closely monitoring vital signs.

Provided exceptional care with a professional demeanor, building a personal connection with the patient and his family to deliver specialized, integrity-driven care.

Virginia Commonwealth University School of Medicine – Richmond, VA

Medical Student

2017 – 2018

Successfully completed MS-1 coursework and gained foundational knowledge and skills in medicine field. Contributed to actively in academic activities and collaborated with peers and faculty to enhance learning and understanding of complex medical concepts.

Sanaria inc. – Rockville, MD

Project Coordinator, PfSPZ Vaccine

2016 – 2017

Conducted due diligence as central point of trial's lead organization, validating all project communications, and gathering pertinent documentation to accurately inform all trial-wide points of contact on project status. Organized conferences and meetings to facilitate data sharing and future planning, ensuring cohesive and informed decision-making processes.

Led meticulous planning, organization, and management of scheduled manufacturing days to ensure high-yield production of the PfSPZ malaria vaccine with protective efficacy in controlled human trials.

Maintained on-call accountability for urgent matters and facilitated communication among domestic and global partners involved in Phase I and II trials and other internal teams, including clinical, quality, research, manufacture, and leadership.

Supported the Chief Executive and Scientific Officer/Principal Investigator of PfSPZ vaccine studies, Stephen L. Hoffman, MD, by providing information assisting in task follow-through related to study.

Chemistry Department, UMBC – Baltimore, MD

Laboratory Teaching Assistant

2015 – 2016

Developed and delivered comprehensive lectures on laboratory components of Chem102L: General Chemistry II Laboratory and Chem124L: Introduction to General, Organic, and Biochemistry, to approximately 30 students. Held office hours to provide student support, assist with questions, and clarify complex concepts. Graded lab reports, exams, and homework and providing feedback to support student learning.

Assisted students in cultivating proper analytical techniques, while enforcing laboratory protocols, safety measures, and fostering a safe learning environment.

Additional Experience

Health Resource Case Manager / Staffing Committee Member Charm City Clinic – Baltimore, MD

Reading Partner Reading Partners, Baltimore City Public Schools – Baltimore, MD

Needle Exchange Program Volunteer Baltimore City Health Department – Baltimore, MD

Microbiology Tutor, Biology Department / Organic Chemistry Learning Assistant, Chemistry Department University of Maryland Baltimore County – Baltimore, MD

Pediatric Emergency Department Volunteer / Team Member, Delirium Prevention Program / Med-Surg Unit Volunteer ST. Agnes Hospital – Baltimore, MD

Education

BA, Biological Sciences, May 2016 (GPA: 3.85/4.00)

University of Maryland Baltimore County (UMBC) – Baltimore, MD

Research Projects

Center for Community Collaboration, UMBC – Baltimore, MD

Psychology Research Assistant Carlo DiClemente, Ph.D.

2014 – 2015

Conducted extensive literature reviews to support ongoing research and grant proposal development, while ensuring comprehensive coverage and relevance to current studies.

Managed and updated a literature database and added detailed article summaries to MDquit.org website to facilitate public access.

Developed educational materials for motivational interview training sessions that enhanced participant learning experiences.

Performed rigorous testing and error-checking on No Wrong Door Integrative Screener (IS) aimed at improving its reliability for clinical use in connecting patients to appropriate care.

Baltimore Traces Project – Baltimore, MD

Ethnographic Field Researcher Michelle Stefano, Ph.D.

2015

Surveyed diverse city neighborhoods, including Highlandtown, Greektown, and Station North to gather data and analyze longitudinal cultural and demographic changes.

Conducted in-depth interviews with residents to capture essential narratives that highlighted community dynamics and historical shifts.

Played a key role in production of multimedia broadcasts, including both radio and video segments, which disseminated research findings and captured the essence of the community’s evolving landscape.

Honors & Awards

Student #1 out of 450+, Fall 2014 CHEM351: Organic Chemistry Accolade, UMBC – Baltimore, MD

Elected Representative & Voting Member, Fall 2014 Tenure & Promotions Committee, UMBC – Baltimore, MD

"Women & Gender Studies Award for Excellence and Research", 2013 – Rockville, MD

Professional Affiliations

Member – Society of Clinical Research Associates, 2020 – Present

Member – The Honor Society of Phi Kappa Phi, 2015 – Present

Member – Omicron Delta Kappa: The National Leadership Honor Society, 2015 - Present

Member – American Medical Association, 2017 – 2021

Treasurer – Apples and Floss for Baltimore, UMBC, 2015 – 2016

President and Founder – Apples and Floss for Baltimore, UMBC, 2014 – 2015

Technical Proficiencies

Electronic Data Capture (EDC) Systems Medidata Rave REDCap Oracle InForm Remote Data Capture (RDC) Documentation Clinical Trial Management Systems (CTMS) Interactive Response Technology (IRT) Electronic Medical Records (EMR) Epic Trial Master File (TMF) & eTMFs Veeva Vault Microsoft Office (Excel, PowerPoint, Word) Smartsheet IND

Contact this candidate