Clinical Research I-Iii
Resume:
Name: Banessa Maldonado
Job title: Senior Clinical Research Associate Consultant
Summary of experience:
Dedicated Clinical Research Associate with more than 11 years of experience. Broad background in clinical trials management of phase I/II/III/IV trials in various indications including the implementation of study protocols, monitoring of sites and on-site data management and collection. Significant expertise in remote data entry (EDC).
Therapeutic area expertise:
Indication
Phase
Clinical phase of the study.
Time on the Project
Time you personally were involved in the project.
Countries
List only those countries (not regions) where you were directly involved /accountable
Services Involved
The capacity in which you worked on the trial/your role on the study.
Atherosclerosis
I/II/III
15 years
US
CCRC-CCRA I-III- Full time
Acute Heart Failure
II
1 year
US
CCRC-CCRA I-III- Full time
Hypertension
I/II/III
15 years
US
CCRC-CCRA I-III- Full time
Thrombosis
I/II/III
15 years
US
CCRC-CCRA- Full time
Dermatology: Acne, Acne Inversa, Allergic Contact Dermatitis, Atopic Dermatitis, Age Spots (Solar Lentigines), Eczema, Hyperpigmentation, Pityriasis rosea, Scleroderma
II/III
3 years
US
CCRC-CCRA- Full time
Diabetes Mellitus Type I
I/II/III
15 years
US
CCRC-CCRA I-III- Full time
Diabetes Mellitus Type II: Diabetic Neuropathy, Peripheral Neuropathy, Distal/Proximal Peripheral Neuropathy (Stages I-IV), Foot (i.e., ulcers, sores, forefoot gangrene, full-foot gangrene)
I/II/III
15 years
US
CCRC-CCRA I-III- Full time
Chronic Kidney Disease
II/III
1 year
US
CCRC-CCRA I-III- Full time
Diabetic Kidney Disease
II/III
1 year
US
CCRC-CCRA I-III- Full time
Metabolic Syndrome
I/II
15 years
US
CCRC-CCRA I-III- Full time
Obesity
I/II
15 years
US
CCRC-CCRA II-III- Full time
Intraocular Lens
I/II
15 years
US
CCRC-CCRA I-II- Full time
Devices: Contacts
I/II
2 years
US
PM - Full time
Devices: Glaucoma Drainage Implant/Minimally Invasive Glaucoma Surgery (MIGS)
I/II
10 years
US
CCRC-CCRA- Full time
Cataract
I/II/III
9 years
US
CCRC-CCRA I-II- Full time
Macular Degeneration Dry
II/III
9 years
US
CCRC-CCRA I-III- Full time
Macular Degeneration Wet
II/III
9 years
US
CCRC-CCRA I-III- Full time
Peripheral Degeneration Retina
II/II
9 years
US
CCRC-CCRA I-III- Full time
Retinopathy
II/III
9 years
US
CCRC-CCRA I-III- Full time
Uveitis
II/III
9 years
US
CCRC-CCRA I- Full time
Keratoconjunctivitis
I/II/III
9 years
US
CCRC-CCRA I-III- Full time
Bipolar Affective disorders
I/II/III/IV
9 years
US
CCRC-CCRA II-III- Full time
Schizophrenia
I/II
9 years
US
CCRC-CCRA II-III- Full time
Major Depressive Disorder
II/III
9 years
US
CCRC-CCRA II-III- Full time
Post-Traumatic Stress Disorder
II/III
9 years
US
CCRC-CCRA I-III- Full time
Attention Deficit Hyperactivity Disorder
II/III
9 years
US
CCRC-CCRA II-III- Full time
Alzheimer's
II/III
9 years
US
CCRC-CCRA II-III- Full time
Sleep Disorders/Insomnia
II/III
9 years
US
CCRC-CCRA II-III- Full time
Asthma
II/III
7 years
US
CCRA III- Full time
Chronic Obstructive Pulmonary Disorder
II/III
7 years
US
CCRA II-III- Full time
Scleroderma
II/III
7 years
US
CCRA III- Full time
Fibrosis of the Lung
II/III
7 years
US
CCRA II-III- Full time
Acne
II/III
7 years
US
CCRA II-III- Full time
Dermatitis
II/III
7 years
US
CCRA II-III- Full time
SARS-CoV-2 & variants vaccine
I/II/III
2 years
US
CCRA III- Full time
Oncology: Breast Cancer Gene I (BRCA I)- Detection Device
I/II
3 years
US, Remote- Mexico, Colombia, and Argentina.
PM- Full time
Oncology: Breast Cancer Gene 2 (BRCA II)- Detection Device
I/II
3 years
US
PM- Full time
Professional experience:
Senior Clinical Research Associate, Ora, LLC (formerly Ora, Inc.), Andover, MA, US (Decentralized)
October 2023 to Present. Contractor via Ora, Inc.
Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gain in-depth understanding of the study protocol and related procedures.
Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
Participate & provide input on site selection and validation activities.
Perform remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased.
Subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.
Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identify, assess, and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Supports audit/inspection activities as needed.
Responsibilities may differ slightly from the above based on specific needs of the business.
Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
Senior Clinical Research Associate, Parexel International, Newton, MA, US (Decentralized)
October 2022 to June 2023. Contractor via Total Med, Inc.
Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).
Build relationships with investigators and site staff.
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
Address and resolve issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training.
Address/evaluate/resolve issues pending from the previous visit, if any.
Follow-up on and respond to appropriate site related questions.
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues.
Determine and implement appropriate follow-up action.
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
Conduct remote visits/contacts as requested/needed.
Generate visit/contact report.
Perform site facilities assessments.
Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training. Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.
Senior Clinical Research Associate, ICON, Raleigh, NC, US (Decentralized)
Nov 2022 to Jan 2023. Contractor through DOCS.
Identified, select, initiate, and close-out appropriate investigational sites for clinical studies.
Monitored those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP.
Performed site facilities assessments.
Depending upon experience, become involved when required in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.
Provided a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Senior Clinical Research Associate, Boehringer, Ingelheim, Ridgefield, CT, US (Decentralized)
October 2021 to October 2022. Contractor via CRN.
Served as a Senior Clinical Research Associate within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the client.
Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
Served as the primary contact for clinical trial sites (e.g., site management).
Contributed towards development of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensured registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed.
Managed/maintained oversight of ordering, tracking, and accountability of investigational products and trial materials.
Senior Clinical Research Associate, Syneos, Morrisville, NC, US (Decentralized)
August 2021 to October 2021. Contractor via Real Staffing.
Assessed site processes.
Conducted Source Document Review of appropriate site source documents and medical records.
Verified required clinical data entered in the case report form (CRF) is accurate and completed via review of site source documents and medical records.
Applied query resolution techniques remotely and on site, and provided guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilized available hardware and software to support the effective conduct of the clinical study data review and capture.
Senior Clinical Research Associate, IQVIA, Durham, NC, US (Decentralized)
August 2020 to August 2021. Contractor via Aerotek/Actalent.
Performed monitoring visits plus maintained appropriate documentation.
Established regular lines of communication plus administered protocol and related study training to assigned sites.
Evaluated the quality and integrity of site practices- escalating quality issues as appropriate.
Managed progress by tracking regulatory submissions, recruitment, CRFs completion, and data query resolution.
Senior Clinical Research Associate, PPD, Wilmington, NC, US (Decentralized)
July 2018 to August 2020. Permanent Employee.
Served as the primary contact with individual investigative sites that conduct clinical research for PPD.
Tracked enrolment status reports to ensure study stayed on track to meet enrolment goals.
Tracked study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team.
Served as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues.
Performed Serious Adverse Event reconciliation and work with team and sites to resolve discrepancies.
Clinical Research Associate II, Syneos Health (formerly) Inventive Health, Morrisville, NC, US (Decentralized)
May 2016 to July 2018. Permanent Employee.
Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits were performed on-site or remotely.
Reviewed completion of proper informed consent procedures.
Interpreted data to identify protocol deviations and risks to subject safety/data integrity.
Generated queries and managed resolutions with site personnel.
Performed investigational product accountability as per the protocol and Study Monitoring Plan.
Clinical Research Associate I, Trial Runners, Dickinson, North Dakota (Decentralized)
December 2015 to May 2016. Permanent Employee.
Conducted Pre-Study, Study Initiation, Interim monitoring, and Close-Out Visits.
Accessed training needs and organized/recommended appropriate training at investigational site.
Participated on development, review, and implementation of project specific monitoring plans.
Monitored activities at assigned investigative sites, ensured that the site was complying to the clinical
investigation plan and ICH/GCP guidelines.
Project Manager, Doheny Eye Institute, Los Angeles, CA
October 2015 to December 2015. Permanent Employee.
Managed clinical trials and served as a direct contact for DIRC's clients and study auditors.
Responsible for study setup, execution, and archival (i.e., start-to-finish oversight).
Developed, wrote, and updated Standard Operating Procedures (SOPs) and work instructions.
Provided ongoing direction to DIRC staff in the performance of study-related tasks, delegated study-related tasks to appropriate staff, and resolved any problems/issues specific to assigned studies.
Coordinated periodic committee meetings for development and discussion of SOP revisions.
Senior Clinical Project Manager, California Health & Longevity Institute, Westlake Village, CA
August 2013 to October 2014. Permanent Employee.
Ensured the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Implemented trial initiation visits and trained multi-sites personnel of the study protocol. Ensured proper site adherence to clinical research regulations. Ensured study staff were conducting the protocol and received the proper materials, instructions, and training to safely enter subjects into the study and complete the protocol requirements, as written.
Conducted site monitoring responsibilities for Clinical trials, according to CHLI Standard Operating Procedures, ICH guidelines and GCP, including Pre-study, Site Initiation, Interim monitoring/analysis visits, and Close-out Visits.
Identified and completed follow-up of SAEs at study site, report SAEs on CIOM-1, sponsor, and regulatory authorities, as pertinent.
Lead Clinical Research Associate, PAREXEL, Glendale, CA, USA
January 2013 to April 2013. Interim contract via Aerotek.
Maintained knowledge and ensured compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g., Project and Monitoring Plan).
Ensured timely completion of role based and project specific trainings.
Completed routine administrative tasks in a timely manner (i.e., timesheets metrics, travel expense claims).
Clinical Studies Coordinator, Davidorf Eye Group, West Hills, CA, USA
November 2006 to December 2012. Permanent Employee.
Performed pre-op and biometry for cataract surgery patients. e.g. IOL MASTER, A-SCAN, Visual Fields and OCT.
Assisted the ophthalmologists with minor surgeries.
Performed annual examinations, pre-op, minor surgeries, outpatient surgeries.
Liaised between Dr. Davidorf and ophthalmic clinical studies sponsors.
Management and coordination of mainly Phase I, II, and III studies; government and pharmaceutical protocols with ophthalmology devices (e.g., CDRH, PMA, IDE, MDR).
Staff Research Associate II, UCLA Health, West Los Angeles, CA, USA
May 2005 to September 2005. Permanent Employee.
Answered phones, filed, data entry management, and primary point of contact for sponsor correspondence.
Data management: maintained PPG database by answering queries and checking for missing information and data collection.
Responsible for quality insurance: reviewed patient charts for missing information and informed CRC of any discrepancies.
Took vital signs; Performed oral glucose tolerance tests, Hyperinsulinemic-euglycemic glucose clamps, specimen preparation for other laboratory studies, and YSI machine performance and quality control.
Dispensed medication to patients for specific clinical research studies and maintained accurate record keeping for all drugs dispensed as part of the clinical research studies.
Research Associate/Intern, California State University Northridge, Northridge, CA, USA
August 2001 to April 2005. Permanent Employee.
Experienced with breeding, weaning, and tagging the spastic Han-Wistar colony.
Sterilized and set-up surgical instruments.
Maintained daily lab records and constructed exercise apparatus.
Acquired extensive training and expertise in neurodegenerative diseases (epilepsy, Alzheimer’s, Parkinson’s disease).
Responsible for performing histology, immunocytochemistry, paraffin cutting, microscopy, image analysis, H&E staining and Nissl staining in the Han-Wistar rat colony.
Education:
California State University, Northridge, CA, B.A. in Liberal Arts, Biology, Biomedical Physics, 2011
Ashford University, San Diego, CA, MBA Healthcare Administration, 2015
Walden University, Minneapolis, MN, PhD Epidemiology, Current (Graduation 2026)
Language skills:
English: Native Speaker, Spanish: Native Speaker
Professional associations:
Association of Clinical Research Professionals
Publications:
Ryan, P., Djellouli, R., & Cohen, R. (2008). Modeling capsule tissue growth around disk-shaped implants: a numerical and in vivo study. Journal of mathematical biology, 57(5), 675–695. https://doi.org/10.1007/s00285-008-0184-0
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