Marlyne Silver

Clinical Research Associate

marlynej@gmail.com | Raleigh, NC | (347) 733-2483

Career Summary
 Clinical research professional with over 14 years of experience in coordinating and managing all aspects of
clinical study operations spanning a broad range of therapeutic area experience including: oncology, neurology,
pulmonary, medical devices and addiction/tobacco.

 Strong working knowledge and experience in executing clinical trial operations, at the site level, according to
ICH-GCP, HIPAA, protocol, study specific plans, IRB, FDA, and SOP guidelines. Aspiring to leverage the
expertise and knowledge gained as a clinical research coordinator in the field as a clinical research associate.

 Demonstrated proficiency in regulatory documentation management and quality review including Investigator
Site Files (ISF) and IRB submissions
PROFESSIONAL EXPERIENCE

Clinical Data Associate, Jan 2023 – March 2024

Collabera/Abbott - Home Based in Raleigh, NC

 Conducts assigned clinical study activities in accordance with applicable regulations, GCP, and
business policies and procedures.
 Managing the clinical study master files to ensure
documents maintained in the file are appropriate and the content of
those documents is accurate, complete and consistent with procedures and regulatory requirements.
 Preparing sites for initiation visits by ensuring supplies are available.
 Preparing necessities for inspection readiness.
 Preparation activities required for regulatory and QA audits.
 Conducting monitoring visits for internal and external clinical studies.
 Participating in site visits to review/ reconcile
 Preparing and submitting written reports, both monitoring and administrative, in a timely,
concise, and objective manner.
 Managing the translation and tracking of translations for appropriate study documents.
 Reviewing clinical data to ensure complete and accurate (e.g.., instrument, assay, and CRF DOL) review
 Appropriately escalating serious outstanding issues to senior level/ clinical management or the
appropriate team members(s).
 Support current and new processes and procedures within the Clinical Affair's organization.
 Performs follow-up for all audit and quality assurance activities.
 Performs study drug accountability, storage and dispensing.
 Support new and innovative process and technologies to increase the quality, productivity, and efficacy.
 Will use applicable knowledge working with other clinical databases/EDC IBM Clinical Development,
(eTMF) ClinPlus, eClinical, Avante (ordering reagents) and SharePoint.
 Supports scheduling and tracking of internal study monitoring visits.
 Supports preparation on training and educational opportunities.

Clinical Research Associate 1, Nov 2021 – Dec 2022

ICON - Home Based in Raleigh, NC

 Identified, selected, initiated, and closed out appropriate investigational sites for sponsored clinical studies.
  Monitored 2 sites in order to ensure that currently assigned study is carried out according to the study protocol
in accordance with ICON’s Standard Operating Procedures, applicable regulations and the principles of ICH-
GCP.
 Performed onsite and virtual interim monitoring visits on a weekly basis in line with site monitoring plan per
protocol.
 Provided protocol specific and study related training to new sites and formed consistent lines of effective
communication with sites to achieve study goals and resolved issues.

Clinical Data Research Associate 1, Feb 2021 – Oct 2021

IQVIA - Home Based in Raleigh, NC

 Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work
and good clinical practice.
 Held accountability for supporting development of project subject recruitment plan on a per site basis.
 Worked with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance
predictability.
 Provided monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
 Administered protocol and related study training to assigned sites and establish regular lines of
communication with sites to manage ongoing project expectations and issues.
 Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and
adherence to applicable regulations.
 Escalated quality issues as appropriate.
 Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment
and enrollment, case report form (CRF) completion and submission, and data query generation and
resolution. May support start-up phase.
 Created and maintained appropriate documentation regarding site management, monitoring visit findings
and action plans by submitting regular visit reports, generating follow-up letters and other required study
documentation.
 Built awareness of features and opportunities of study to site.
 Collaborated and liaised with study team members for project execution support as appropriate.

Clinical Data Research Coordinator, May 2018 – Sep 2020

Rose Research Center - Raleigh, NC
 Conducted and documented the informed consent process for clinical trial subjects in 8 study protocols
 Provided insight in the development and modification of study/site-specific documents including protocols,
informed consent forms (ICF), case report forms (CRF), study manuals, and monitoring tools
 Established self-driven work ethic to accomplish the ongoing monitoring and evaluation of the clinical trial’s
progress and data integrity at the site level; Organized and maintained investigator site files (ISF) including study
logs and other regulatory documents; maintained effort to build relationships with clinical research monitor(s)
via verbal and electronic communication
 Observed collection of visit assessment details to ensure accuracy of all study subject records
 Collected, processed, and shipped laboratory specimens to central laboratories
 Conducted medical records review to determine subject eligibility
 Performed transcription/data entry into electronic document management system, MEDRIO; Reviewed
completed source documents and case report forms (CRFs); Exercised strong problem-solving skills to achieve
corrective actions and complete query resolutions in a timely manner
 Effectively demonstrated ability to manage multiple tasks by overseeing and conducting all research studies
according to protocol, good clinical practices (GCP), standard operating procedures (SOPs), and all other
study specific & regulatory guidelines
 Trained, supervised, and directed entry level site staff of 4 to prioritize completion of all study activities in
accordance with study protocols using verbal communication and electronic communication tools; achieved
increased productivity resulting in smoother workflows and reduced wait time for screening visits; Applied a
flexible approach to train entry level staff to maintain team morale and unity
Senior Clinical Data Specialist, August 2017 – May 2018
Duke Cancer Center - Raleigh, NC
 Executed clinical trial operations related to the collection and documentation of research data for 12 + studies
simultaneously
 Consented and screened subjects for minimal risk studies; Scheduled and conducted subject visits
 Employed strategies to maintain recruitment and retention rates; Assisted subjects with special needs
 Collect, prepare, and process adverse events (AE) and serious adverse events (SAE) information
 Completed timely and accurate data entry on paper and electronic Case Report Forms (CRFs and eCRFs) in
Electronic Data Capture (EDC) systems, as well as provide training for other study staff
 Assisted with source document development and quality management
 Investigated incomplete, inaccurate, or missing data/documents to ensure accuracy, quality, and
completeness of data; Maintained inventory and quality of study supplies and equipment
 Collected, prepared, processed, shipped, and maintained inventory of laboratory specimens; utilized
communication skills and hands on demonstrations to train others in these tasks
 Assisted with the development of protocol-specific systems and documents including process flows
 Utilized strong written and verbal communication to efficiently work with study personnel to execute clinical
trials

Clinical Data Coordinator, May 2016 – August 2017

Duke Asthma, Allergy & Airway Center - Durham, NC
 Executed subject consenting, screening, enrollment, and scheduled visits for 4 clinical studies
simultaneously per PI delegated responsibilities
 Facilitated data collection, compilation, documentation, and analysis of 4 protocols using clinical trials
management systems, Inform and RAVE.
 Coordinated effective communication and built close relationships with clinical research associates to complete
site document verification. Accomplished resolutions to outdated queries, missing data; reviewed completeness
of forms and evaluated overall data integrity.
 Coordinated IP orders, drug accountability with in-house pharmacy, laboratory procedures and
treatments for study subjects
 Collected and reviewed data from EMR, subject interviews, questionnaires, diagnostic tests, and other sources,
for study eligibility purposes; Evaluated and interpreted collected clinical data in conjunction with principal
investigator
 Ensured compliance with protocol, IRB, SOPs, and other regulatory guidelines
 Identified medical records’ problems and inconsistencies, recommended corrective actions
 Monitored subjects’ progress, focusing on proper documentation, and reporting of adverse events

Clinical Trials Assistant II, Mar 2010 – May 2016

Duke University - Center for Applied Genomics & Precision Medicine - Durham, NC
 Coordinated and conducted study visits for over 200 subjects; Developed research study reports
 Executed IRB submissions, managed budget, administrative planning, and execution of studies fund
 Aided in protocol development of new studies, Designed study advertisement materials
 In accordance with ICH guidelines, an honest and ethical approach was provided during all informed consent
processes, enrollment, and the documentation of over 200 subjects of diverse backgrounds for Genetics of
Memory, Schizophrenia and Cognition and Other Normal Variation Studies per protocol, GCP and regulatory
guidelines
 Performed over 200 blood draws for a diverse age group; Managed study laboratory samples; Maintained
blood specimens’ database for all clinical studies; Trained new clinical research staff
 Secured subject safety and confidentiality per protocol and institutional guidelines for the protection of the
patient during and after study participation; Engaged verbal communication skills to ensure safety

PRIOR WORK HISTORY

Administrative Assistant | Shaw University | NC | Nov 2009 – Jan 2010
Project Coordinator | Greater Brooklyn Health Coalition | Brooklyn, NY | Jun 2008 – Apr 2009

EDUCATION
B. A. in Health & Nutrition Science | Brooklyn College | Brooklyn, NY | May 2009

TECHNICAL PROFICIENCIES
 EDC Systems (Inform, Rave, Medrio, REDCap)  Other Systems (Epic, Progeny Clinical Software)
 Microsoft Office (Word, Excel, PowerPoint, Outlook)  TMF (Wingspan, pTMF, eTMF, ELVIS,
ICOMaster)
 Clinical Trial Management Systems (CTMS, SIEBEL, ICOTrial)
 Project Management Tools (Microsoft Planner, SharePoint, Trello, OneNote)
 Safety Reporting Systems (Site-based centralized SRS, LifeSphere, SIRIUS)

Therapeutic Phase Role/Capacity Number of # of Years in Indications

Area Studies Experience
Neurology I-III Clinical Trials 5 6 Memory,
Assistant Cognition,
Alzheimer’s,
Schizophrenia,
ALS
I-IV Clinical 7 0.7 Alzheimer’s
Research Disease
Associate (Blinded
Monitor)

Amyotropic
Lateral
Sclerosis
(Unblinded
Monitor)
Pulmonary II-III Clinical 4 1 COPD, Asthma
Research
Coordinator
Oncology II-III Senior Clinical 14 (includes 1 Non-Small
Research sub studies) Cell/Small Cell
Specialist Lung, Breast,
Colorectal,
Colon, Prostate
Tobacco & II-III Clinical 8 2 N/A
Smoking Research
Cessation Coordinator
Vaccines I-II Clinical 2 0.7 Respiratory
Research
Associate
Gynecology III Clinical 1 0.5 Vasomotor and
Research Menopausal
Associate Symptoms
Oncology: Prospective Clinical 3 1.4 Myeloma
Medical Research
Devices/In vitro Associate
Diagnostics