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Marie Perez personal email
A clinical research management professional with 20 years in the research and development arena from site management to study management. Deliver every clinical aspects of the study from study start-up to close-out. Oversee the clinical portion of the study, eTMF, monitoring plans, tools, train CRAs, drive enrollment and study start-up activities. Manage, collaborate with vendors & cross-functional teams on tracking and deliverables. Responsible to negotiate, manage budgets with CROs, vendors and sites. Train and coordinate activities of study team members, as requested. Responsible for serving as part of a cross functional team in planning and delivery of a defined internal audit, quality review process and provide study audit responses, as needed. Identify & mitigates risks. Provide monitoring reporting & metrics on clinical activities.
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Global Study Delivery LeadGsk Jun 2022 - PresentBrentford, Middlesex, Gb -
Clinical Research ProfessionalBeacon Hill Staffing Group Mar 2022 - Jun 2022Boston, Ma, Us -
Clinical Trial ManagerProgenity, Inc. Apr 2021 - Mar 2022
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LcraThe Steely Group (Horizon Therapeutics) May 2019 - Apr 2021La Grange, Il, Us -
Sr. Cra IiPharm-Olam, Llc Aug 2018 - Apr 2019Houston, Tx, Us -
Principal CraKolon Tissuegene, Inc. Mar 2018 - Jul 2018Rockville, Maryland, Us -
Sr. Site ManagerDocs Global Sep 2015 - Mar 2018
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Clinical Research Associate IiPra International Jun 2012 - Sep 2015Raleigh, North Carolina, Us• Develop and maintain study tracking reports• Monitor (pre-study, initiation, interim, and close-out visits) investigator sites for GCP compliance according to applicable SOP’s and/or guidelines • Investigator recruitment, including budget/contract negotiation• Negotiate study budgets with investigators• Obtain, review, and process regulatory and administrative documents from investigator sites• Review and develop protocols, CRFs, CRF Completion Guidelines and trip report templates• Coordinate at Investgator Meetings• Review Serious Adverse Event (SAE) reports• Prepare project management reports for clients, project personnel, and management• Resolve issues, questions, and requests for additional study supplies• Review and verify completed CRFs (paper and electronic)• Review clinical data in-house• Resolve queries of CRF data with study site personnel• Train and mentor CRAs on monitoring, internal procedures, and query resolution -
Clinical Research AssociatePharmanet Development Group, Inc. Dec 2008 - May 2012Raleigh, North Carolina, Us•Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PharmaNet SOPs and/or client guidelines•Recruit investigators for participation in clinical trials•Negotiate study budgets with investigators•Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites•Review draft protocols for completeness and feasibility•Develop Case Report Forms for clinical trials•Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings•Prepare and process Serious Adverse Event (SAE) reports •Prepare project management reports for clients, project personnel, and PharmaNet management•Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries•Resolve queries of CRF data with study site personnel•Review Tables and Listings generated from study data •Assist in writing Clinical Study Reports -
Clinical Research Coordinator - Spinal Cord InjuryRehabilitation Institution Of Chicago Jun 2008 - Dec 2008•Maintained clinical database including obtaining subject consent, extracting data from medical records and review exclusion and inclusion criteria for each subject•Coordinated research projects including preparing and maintaining IRB documents, subject consents and grant budgets•Performed clinical procedures for research purposes•Responsible for CRF’s, data queries completion, drug inventories, IVRS, patient •Served as a liaison between patient and physician or research staff and coordinated activities with all involved departments
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Clinical Research Associate/Project ManagerClinical Resource Network, Llc, Jun 2007 - Jul 2008Therapeutic areas – coronary artery disease, cardiology, immunology, primary immune deficiency disease•Responsible for coordinating and managing contracted homecare services in the support of sponsored Phase I – IV clinical trials in a variety of therapeutic areas•Functioned as a liaison between sponsor, study investigator site, and CRO•Reviewed and monitored research study for completeness, accuracy, enrollment, data collection, and adherence to protocol and GCP/ICH/FDA requirements•Responsible for study invoices and secure study procedure payments accordingly•Trained subcontracted personnel on study requirements and procedures•Developed study material: contracts, proposals, clinical training manuals and data forms
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Clinical Research CoordinatorHines Va Hospital, Chicago Association Of Research Aug 2004 - Jun 2007Therapeutic areas – pulmonary/respiratory (COPD)•Responsible for the development and implementation of numerous clinical study protocols•Responsible for all regulatory documents completion according to federal regulations•Reported SAE’s, amendments, protocol deviations/violations to sponsor and IRB•Conducted all protocol procedures on the research study participants•Screened, interviewed and enrolled patients accordingly per inclusion and exclusion criteria•Responsible for CRF’s, data queries completion, drug inventories, IVRS, patient enrollment •Provided mentorship to new researchers, coordinators, and PI’s
Marie Perez Skills
Marie Perez Education Details
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University Of Illinois ChicagoBs
Frequently Asked Questions about Marie Perez
What company does Marie Perez work for?
Marie Perez works for Gsk
What is Marie Perez's role at the current company?
Marie Perez's current role is Study Delivery Lead (Global).
What is Marie Perez's email address?
Marie Perez's email address is mp****@****net.com
What schools did Marie Perez attend?
Marie Perez attended University Of Illinois Chicago.
What are some of Marie Perez's interests?
Marie Perez has interest in Social Services, Children, Health.
What skills is Marie Perez known for?
Marie Perez has skills like Clinical Trials, Gcp, Cro, Human Resources, Project Management, Clinical Research, Protocol, Sop, Therapeutic Areas, Irb, Clinical Study Design, Biotechnology.
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