Rachel E Garris

Cary, NC ***** ad0ln9@r.postjobfree.com 919-***-****

Clinical Research Associate/Lead Research Associate Professional CRA with over 10 years of experience in clinical trials at a CRO, coordinating studies from start-up through monitoring and termination phases. Expertise in the implementation of study protocols, monitoring of sites, data management and collection, and quality assurance. Regularly promoted for accomplishments throughout the research career path and excelling at each role achieved, including the Lead CRA role. As Lead CRA, manages the team to ensure performance and achievement of key metrics, conduct training, mitigate potential compliance issues, and assist in meeting critical project deadlines put forth by the sponsor. Therapeutic Area Expertise

Vaccines Phase I, II, III Start-up, Monitoring, Termination Oct 2020 – Present Gastroentrology Phase II Monitoring Nov 2017 – Oct 2018 Dermatological Phase III Monitoring Nov 2014 – Nov 2016 Neurology Phase III Start-up, Monitoring Dec 2018 – Oct 2020 Cardiology Phase IIb, III Monitoring, Termination Jan 2017 – Oct 2020 Covid-19 Phase I Start-up, Monitoring Jan 2018 – Oct 2020 Neurology Phase II Start-up, Monitoring Nov 2015 – Jan 2017 Rheumatology Phase II Monitoring, Termination Nov 2014 – Nov 2015 Rare Disease Phase II Monitoring Nov 2016 – Oct 2017 PROFESSIONAL EXPERIENCE

Icon, Durham, NC December 2021 – Present

Lead CRA

Assists project manager by monitoring clinical trial performance and ensured quality metrics were met by reviewing CRA reports and successfully averages a 99% MVR submission compliance for the assigned study, surpassing company metric of 95% through prompt review of MVRs, holding CRAs accountable for accurate and timely work, and outlining all corrections clearly and concisely to prevent multiple revisions and submissions.

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Ensures validity of study information by tracking clinical study data within the study database, such as eCRFs, source documents, diagnostic reports, inventory logs, deviation and issues reports, and SAE/AE trackers to identify and resolve discrepancies or obtain missing data.

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Supports study quality by mentoring CRAs, completing quality control visits, resource on study to handle company-related and protocol specific questions, creating study specific tools as needed for sites and CRAs relatng to data, IP/NIMP, and sample management.

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PRA Health Sciences, on assignment with Sanofi, Durham, NC October 2020 – December 2021 Senior/Lead CRA

PAREXEL INTERNATIONAL, Durham, NC November 2015 – October 2020 Clinical Research Associate I/II

● Main Performs point source of contact data verification for all sites including and follow-management up of data queries of trial at deliverables the site level, and ongoing resolving review escalations. of Risk Based Monitoring information and other factors influencing data quality and frequency of required site visits.

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Assists in the creation and review of informed consents, case report forms, study operations manuals,

● monitoring tools, and other study-related materials. Was in a customer-facing role, and worked to build business relationships and represent our company with

● investigators.

● Shares Ensures protocol-no Critical specific Audit or information Inspection Findings and best through practices review across of study countries\documents clusters. at each visit and

● administers quality assurance for all filed documents. Provides weekly project updates on critical study information including enrollment, site status, CRF and

● DCF status, and adverse events.

Prepares onsite review and follow-up activities in compliance with the Monitoring Plan, Protocol, and SOPs

● including appropriate ISF maintenance, IP management, sample management, and safety reporting. Presents weekly meetings to study teams and clients including training, review of study expectations and

● timelines, database lock, study compliance, qualifications of sites, and other critical study metrics. Documents the start-up of study, updates core documents to specific study requirements, and creates

● materials for the Site Initiation visit to be provided to the CRA for use at the site. Assists the Project Manager with any tasks that require immediate attention such as pulling issues and deviation reports, collection of important site information for start-up, and meeting on sponsor team calls to discuss study.

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Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems,

● IVRS/IWRS, and Electronic Data Capture platforms.

● ● Assigned Served Tracks site-as to subject level the most progress matter complex expert to ensure studies for timely CTM and on data sites monitoring-collection, to provide related source leadership activities. document in the delivery verification, of services and query to clients.

● resolution.

Implemented and monitored clinical trials to ensure sponsor and investigator obligations were being met and ensured compliance with the applicable local regulatory requirements in accordance with ICH-GCP guidelines.

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Assessed the qualifications of potential investigative sites, initiated clinical trials at the investigative sites,

● instructed site personnel on the proper conduct of clinical trials, and performed close-out of the trials. Managed trials and provided regular site status information to team members, updated trial management

● tools, verified accuracy of clinical trial data collected, and completed any monitoring activity documents. Identified site, trial, and clinical issues per company SOPs, escalating when appropriate, and worked any

● identified issues through to resolution.

● ● ● Performed Assessed Updated all IP source accountability, applicable document tracking dispensation, verification, systems, facilitated and reconciliation, compliance audits and at and the query resolution, investigator resolution. and site. managed trial timelines. Acted as clinical site’s main point of contact, accountable for quality and deliverables from site Initiation to

● Close-out of the trial.

● Directed trial at designated sites and ensured rights and well-being of subjects were protected. PAREXEL, Durham NC November 2014 - November 2015

Clinical Monitoring Associate

LABCORP, Durham, NC March 2014 – November 2014

Molecular Genetcs Laboratory Technologist

Ensured quality and integrity of the data, site compliance with protocol, study requirements, GCP and

● conformance with any applicable regulatory requirements. Conducted Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generated contact and

● site visit reports in compliance with the monitoring plan. Ensured timely and accurate access and updates of applicable trial management systems and trial master file documents and assisted in managing clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress.

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● ● Assisted Managed team test articles, leads by study prepping supply, and accountability, running weekly and team destruction/meetings. return status Reviewed site recruitment plans and acted to drive recruitment in collaboration with the site staff on an

● ongoing basis.

Maintained sound working knowledge of and ensured compliance with applicable ICH- GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL/ Sponsor training requirements and study specific procedures, plans and training.

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● Worked Utilized site independently management and experience managed and multiple understanding priorities to of deliver clinical project trials methodology results within to timelines. demonstrate

● leadership and problem solving.

● ● ● ● Accountable Mentored Handled Actively participated critical junior for financial the staff. review in Investigator matters and maintenance such and as other site payments. of meetings, study Trial audits, Master and Files regulatory (TMF). inspections. Conducted specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation.

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Performed all clinical monitoring tasks and remote visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines to always ensure patient safety and data integrity.

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Acted as PAREXEL's remote contact with assigned clinical sites and used judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites including managing/supporting site activities remotely, resolving site issues, and ensuring timely and high-quality data entry at the site level.

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● Performed Collected Nano isolation Drop of Spec irreplaceable data and input samples the for data DNA to construct to conduct graphs, further charts testing and and calculate analysis. averages and

● standard deviations to determine the quality control of the samples extracted.

● Assisted Able to multitask in revising by Standard running multiple Operating testing Procedures protocols for protocols and maintained utilized a in clean the laboratory. workspace to minimize any

● contamination.

● ● ● ● Performed Conducted Maintained Tracked samples quality training quality using control sample of DNA database of extractions extraction equipment, and/or protocols with manual new high reagents, applications. for turnover bloods, and for amnios controls. quick and sample casuals. output and results. EDUCATION

Bachelor of Science (B.S), Biochemistry

North Carolina State University, Raleigh, NC

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