Clinical Research Professional
Resume:
MARINA R. FISHBEIN
443-***-**** **************@*****.*** D.C. Metropolitan Area
EDUCATION University of Maryland Baltimore County (UMBC)
BA, Biological Sciences, May 2016
GPA 3.85
EXPERIENCE SUPPORTIVE & OCCUPATIONAL CARE FOR FAMILY MEMBER Baltimore, MD Care Provider and Family Member (UNPAID) 07/2023 – 04/2024
(More than willing to discuss my need to dedicate myself to full-time support a family member whose health was in decline, if requested.)
PREMIER RESEARCH INTERNATIONAL, LLC Remote/Northeast Region Clinical Research Associate 04/2022 – 06/2023
-Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
-Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
-Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
-Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
-Monitors with knowledge of quality/scope/timeline and budget parameters
-Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates
-Maintains project tracking system of subjects and site information, as applicable
-Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts
-Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
-Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
-Reviews IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
-Completes all required internal training (general and study-specific) on-time
-Acts as a resource for other CRAs and shares knowledge base and best practices
-Other activities as designated
• Focused Experience: Diagnostics, infectious disease
• eTMF Experience: Trial Interactive, Rave eTMF, Veeva Vault
• Tracking/Software: Smartsheet, Microsoft Office
SUPERNUS PHARMACEUTICALS Rockville, MD
In-House Clinical Research Associate 08/2021 – 03/2022 01MAY2024
-Responsible for those aspects of clinical monitoring and site management that can be accomplished remotely in accordance with applicable Standard Operating Procedures (SOPs) as well as the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP).
-Consult with management staff to ensure compliance with standard protocol, regulatory and GCP obligations in assigned tasks of clinical site monitoring; collect documents, review data points/findings from electronic data capture (EDC) and review accuracy with source; review and appropriately escalate site quality, performance, and safety, and provide required trial status reports to project management; write, follow, and resolve clinical queries on various electronic databases (EDCs)
-When needed, assist with individual site recruitment activities utilizing phone scripts, questionnaires, study site materials, and other tools for evaluating investigative sites; ensure audit-readiness in terms of regulatory document upkeep by site staff, and serve as general resource to assist them in conducting trial according to protocol in order to maintain priority of study participants’ protection and safety.
• Focused Experience: CNS
• eTMF Experience: Trial Interactive
• Software: Microsoft Office
JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE Baltimore, MD Study Coordinator Apprentice 01/2020 – 08/2021
-Serving as primary contact in communication and correspondence with study participants, other departments, CROs, and sponsors
-Reading scientific protocols and preparing study reports and materials, while working with the principal investigator and other study team members to amend, develop, and execute study protocols
-Preparation and submission of protocol for institution’s IRB application, and maintaining/updating IRB application
-Prescreening patient participants, comparing inclusion/exclusion criteria of eligible candidates; introducing and consenting study participants; assisting participants through scheduled visits as outlined in protocols
-Participating in site initiation visits, remote monitoring visits, close-out visits
-Data entry and resolving queries in eCRFs with within EDCs, including Oracle/InForm, Medidata/Rave, REDcap
-Obtained blood for processing, packaging, labeling and shipping to ensure quality samples
-Maintaining knowledge and certifications in Good Clinical Practice, Human Subjects Research, IATA, and ICH requirements.
-Completing courses and lectures in progressively advanced topics in research coordination through Johns Hopkins University
-Training in Clinical Rotation Units by determining vital statistics such as height, weight, temperature, pulse, blood pressure, respiratory rate and 12-lead ECG; obtaining and practicing phlebotomy skills for patient
-Using universal safety precautions to protect self and co-workers from bio-hazardous materials, including blood-borne pathogens
• Focused Experience: Neurology, infectious disease, gastroenterology, rare disease
• eTMF Experience: Veeva Vault
• Software: Microsoft Office
THE MARINI* HOME PRIVATE CARE Damascus, MD
Respite Care Provider 01/2019 – 07/2019
-Part-time care for 12-yo boy on life-support
01MAY2024
-Administration of medications & fluids via G-tube; sterile maintenance of trach/G-tube openings and ports; changing diapers and catheterization to manage fluid retention, monitoring vitals
-Ensuring highest quality of comfort and care; behaving professionally while connecting personally with patient and his family members to provide specialized care with uncompromised integrity
*Permission to disclose name was granted by family to which healthcare of child was provided. VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE Richmond, VA Medical Student 08/2017 – 09/2018
-MS-1 coursework; subsequently withdrew from MD program SANARIA INC. Rockville, MD
Project Coordinator, PfSPZ Vaccine 05/2016 – 07/2017
[Biotech company that developed and sponsored clinical trials of malaria vaccine known as PfSPZ]
-Carried out deliberative planning, organization and management of scheduled manufacturing days in order to achieve a high yield production of vaccine product with protective efficacy against malaria in controlled human trials
-Performed due diligence as branch-point of the trial’s lead organization: i. Ensured the validity of all project communications; gathered pertinent documentation & information before thoroughly informing on project status to all points of contact trial-wide ii. Committed to on-call accountability in response to urgencies that necessitated immediate attention from all Sanaria’s internal teams (clinical, quality, research, manufacture, and leadership), facilitated a network of collaboration and ensured highest-priority-exchange of communication between
multiple domestic and global partners of Phase I and II PfSPZ Vaccine trials iii. Organized conferences/meetings to facilitate sharing of data and future planning
-Closely staffed Chief Executive & Scientific Officer/Principal Investigator of PfSPZ vaccine studies, Stephen L. Hoffman, MD, providing organization, information, and pressure necessary to propel his follow-through on tasks in relation to the study
• Focused Experience: Infectious disease, vaccines
• eTMF Experience: Not applicable
• Software: Microsoft Office
CHEMISTRY DEPARTMENT, UMBC Baltimore, MD
Laboratory Teaching Assistant 09/2015 – 05/2016
-Instructor for the laboratory component of Chem102L: General Chemistry II Laboratory, and Chem124L: Introduction to General, Organic, and Biochemistry: -Provided demonstrations and comprehension- focused-instruction to ~30 students
-Enforced protocols & safety measures, and took care to ensure the development of student’s proper analytical techniques; held office hours for student support; graded lab reports, exams, homework SERVICE CHARM CITY CLINIC NPO, staffed by volunteers Baltimore, MD Health Resource Case Manager VOLUNTEER Healthcare IS a human right 08/2014 – 10/2016
-Built longitudinal relationships with clients on my caseload & fellow clinic case managers, and contributed to an environment of safety, unity & free exchange of knowledge where we could serve our clients’ basic unmet needs -Engaged with organizations and healthcare providers in our community—via 01MAY2024
homeless shelters, treatment centers, food banks, general practitioners and specialists—created a network with resources at our disposal that could provide immediate and long-term solutions to our clients
i. Linked clients and their families to various health care services, from primary or specialty care, to the T.I.K.E. Van offering free vaccinations for children in need ii. Enrolled clients in services such as the Maryland Food Supplement Program, Medical Assistance, Medicare, public housing assistance, etc.
Staffing Committee Member VOLUNTEER 1 of 3 elected members 06/2016 – 10/2016
-Tasked to fill the clinic’s staffing needs, with the most-dedicated, and best-qualified, clinical and non- clinical volunteer; Reviewed candidate applications in order to select two cohorts of new volunteers,
-Lead new volunteers through the mandatory health resource case management training READING PARTNERS, BALTIMORE CITY PUBLIC SCHOOLS Baltimore, MD Reading Partner 11/2015 – 05/2016
-Providing individualized reading instruction to K-5 children that were at least one month behind in grade level proficiency, in accordance with Reading Partner’s standardized proven program BALTIMORE CITY HEALTH DEPARTMENT Baltimore, MD
VOLUNTEER Needle Exchange Program Volunteer 06/2014 – 03/2015
-Distributed harm reduction kits and exchanged needles on a one-to-one basis
-Observed and supported program staff in community as they: discussed strategies of risk reduction, instructed on overdose prevention, conducted testing for HIV and Hepatitis C for sexually transmitted disease, following up with seropositive individuals to ensure they were connected to proper care UNIVERSITY OF MARYLAND BALTIMORE COUNTY Baltimore, MD VOLUNTEER Microbiology Tutor, Biology Department 01/2015 – 06/2015
-Assisted students’ understanding of fundamental concepts in microbiology; reviewed lab reports and assignments for students to revise prior to submission VOLUNTEER Organic Chemistry Learning Assistant, Chemistry Department 05/2015 – 08/2015
-Assisted organic chemistry students during classroom activities; planned and carried out comprehensive review sessions with semester’s students ST. AGNES HOSPITAL Baltimore, MD
VOLUNTEER Pediatric Emergency Department 08/2013 – 09/2014
-Observed and assisted during minor medical procedures; e.g., holding to keep infant/child still, providing a distraction, etc.
-Provided general and emotional support to children and families through their visit to the emergency department
Team Member Delirium Prevention Program 08/2013 – 09/2014 Assessed older patients for risk and presence of delirium, acting as liaison between patient and chief psychiatrist, Dr. Paul McClelland
-Worked to maintain cognitive engagement of patients through activities like reading, solving puzzles, and conversation
VOLUNTEER Med-Surg Unit 08/2013 – 05/2014
-eAssisted in bathing, cleaning and reading to patients; provided food and beverages to our patients at mealtimes, and when needed, helped them to eat
01MAY2024
RESEARCH CENTER FOR COMMUNITY COLLABORATION, UMBC Baltimore, MD Psychology Research Assistant Carlo DiClemente, Ph.D. 08/2014 – 12/2015 Conducted comprehensive literature reviews; reviewed grant proposals; maintained literature database, wrote and added article summaries to MDquit.org website; prepared materials for motivational interview trainings; tested and carried out error checking of the No Wrong Door Integrative Screener
(IS), a tool for improving connection to care; Integrative Screener data entry and analysis BALTIMORE TRACES PROJECT Baltimore, MD
Ethnographic Field Researcher Michelle Stefano, Ph.D. 01/2015 – 07/2015 Surveyed the landscape and residents in the Baltimore City neighborhoods of Highlandtown, Greektown, and Station North to understand their longitudinal cultural and demographic changes; contributed to creative production of both a radio and video broadcast of findings using interviews conducted with residents.
HONORS CHEM351: ORGANIC CHEMISTRY ACCOLADE, UMBC Baltimore, MD Student #1 out of 450+ Fall 2014
-In a class of nearly 500 students, completed semester having earned the highest overall grade in UMBC’s undergraduate Organic Chemistry course
TENURE & PROMOTIONS COMMITTEE, UMBC Baltimore, MD
Elected Representative & Voting Member Fall 2014
Selected as sole undergraduate member to represent my fellow student body on committee; carried out an extensive, objective evaluation of professor’s comprehensive teaching portfolio; analyzed and interpreted qualitative and quantitative student feedback; presented results of analysis and conclusion to tenured faculty of the Psychology Department; voted with the committee
"Women & Gender Studies Award for Excellence and Research" Rockville, MD Recipient 2013
MEMBERSHIPS SOCIETY OF CLINICAL RESEARCH ASSOCIATES
Member 2020 - present
AMERICAN MEDICAL ASSOCIATION
Member 2017 – 2021
THE HONOR SOCIETY OF PHI KAPPA PHI
Member 2015 – present
“must rank scholastically in the top 7.5% of undergraduate class” OMICRON DELTA KAPPA: THE NATIONAL LEADERSHIP HONOR SOCIETY Member 2015 – present
“to give recognition and honor for meritorious leadership and service in extracurricular activities and encourage development of general campus citizenship” 01MAY2024
APPLES AND FLOSS FOR BALTIMORE, UMBC
Treasurer 2015 – 2016
President and Founder 2014 – 2015
A UMBC student organization that fundraises in order to provide basic dental necessities and fruit to underserved populations in Baltimore City
SKILLS Standard Operating Procedure (SOP) Review International Council for Harmonisation (ICH) Good Clinical Practice (GCP) SOP Compliance Hazardardous Materials Shipping and Packaging Source Documentation Review Source Documentation Verification Data Analysis Data Integrity Data Entry Informed Consent Contract & Budget Negotiation Editing Written Communication Verbal Communication Clinical Operations Patient Care & Safety Human Subjects Research Electronic Case Report Form (eCRF) Electronic Data Capture (EDC) Systems Medidata Rave REDCap Oracle InForm Remote Data Capture (RDC) Documentation Remote Data Verification Clinical Trial Management Systems (CTMS) Interactive Response Technology (IRT) Protocol Compliance Protocol Review Serious Adverse Event (SAE) Reporting Adverse Events Clinical Trials Clinical Research Organization (CRO) Sponsored Clinical Research Trials Investigator-initiated Studies FDA Guidance FDA Compliance Audit Compliance & Readiness Electronic Medical Records (EMR) Epic Trial Master File (TMF) & eTMFs Veeva Vault Trial Interactive Community Outreach & Recruitment Leadership Teamwork Site Management Clinical Site Monitoring Remote Site Monitoring Feasibility Assessments & Site Qualification Visits Investigator Meetings Interim Monitoring Visits Close-out Visits Drug Reconciliation Microsoft Office Microsoft Excel Microsoft PowerPoint Smartsheet Pharmaceutical Industry Due Diligence Healthcare Case Management Public Health Epidemiology Infectious Disease Neurology Gastroenterology Diagnostics Vaccines Rare Disease Drug Accountability IND Phase I Phase II Phase III Phase IV Open-label Study Interventional Trial Observational Trial
List of Professional References FISHBEIN, MARINA Referee’s information is provided below as follows: NAME OF REFEREE
Title, Present Employer
Relationship to Candidate
Phone Contact
Email Address
STEPHANIE SWORDS
Research Program Administrator, JHUSoM – ICTR
Direct Supervisor while in Study Coordinator Apprenticeship & Mentoring Program
********@****.***
SHIRLEY ZIMMERMAN, RN
Manager of Clinical Operations, Premier Research International, LLC Direct Supervisor (Line Manager) while working as CRA
01MAY2024
*********@*****.***
TONJA HOWELL
Clinical Program Manager, Syneos Health: Sponsor-dedicated – Guilead Direct Supervisor while working as In-House CRA at Supernus Pharmaceuticals
*********@*****.***
STEPHEN CAPELLO, CCRP
Research Program Coordinator, JHUSoM – ICTR
Former colleague during candidate’s prior employment within the ICTR
********@****.***
MIGUEL REYES
Clinical Research Associate II, ICON Strategic Solutions: Sponsor-dedicated – Sanofi Former colleague at Premier Research International, LLC
******.*****@*******.***
VINEET KAUR CHAGGAR, OMFS
Lead Clinical Research Coordinator, Science 37
Former CRC at research site monitored by candidate during time as CRA
****.******@*******.***
ANDREA HENRY-ROANE
Regulatory Coordinator, Centennial Medical Group of Elkridge, MD CRC and Regulatory Coordinator of research site monitored by candidate during time as CRA
******@*****************.***
SAMUEL “DOZIE” OKAFOR, PharmD
Clinical Research Associate II, Premier Research International, LLC Former colleague at Premier Research International, LLC
******.******@*******-********.*** (preferred method of contact) ASHLEY PARKER
Senior Clinical Research Associate II, Syneos Health Former colleague at Premier Research International, LLC & member of team that trained candidate in their first few monitoring visits
*******@*****.*** (preferred method of contact)
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