María Carranza Jiménez, MSc
Project Management Assistant/CRA at IKF - Institute of Clinical Cancer Research- Claim this Profile
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Español Native or bilingual proficiency
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Ingles Full professional proficiency
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Bio
Mayte Mejias Aranguren , BSC, MSC
Durante el tiempo que trabajamos en la misma compañía pude contagiarme de Maria de la excelente actitud y positividad. Siempre demostrando interés y responsabilidad en sus tareas y con una enorme empatía y respeto hacia los que le rodean.
Eduard Cabré Estivill, PhD
I worked with María Carranza in various clinical trials in the field of hemato-oncology at MFAR. María has effectively collaborated in analyzing and reporting results from clinical trials, performing remote monitoring visits, reporting safety events of investigation products, and ensuring the start-up documentation is ready for all centers participating in various clinical trials. During the 7 months we have worked together, she demonstrated high engagement and motivation. Besides, she had a key role in ensuring all regulatory aspects of clinical trials we were managing were kept following the GCP standards. María's greatest abilities are her capacity to learn quickly and her level of commitment to the job that she is developing. She is also enthusiastic and proactive so I definitely would recommend María.
Mayte Mejias Aranguren , BSC, MSC
Durante el tiempo que trabajamos en la misma compañía pude contagiarme de Maria de la excelente actitud y positividad. Siempre demostrando interés y responsabilidad en sus tareas y con una enorme empatía y respeto hacia los que le rodean.
Eduard Cabré Estivill, PhD
I worked with María Carranza in various clinical trials in the field of hemato-oncology at MFAR. María has effectively collaborated in analyzing and reporting results from clinical trials, performing remote monitoring visits, reporting safety events of investigation products, and ensuring the start-up documentation is ready for all centers participating in various clinical trials. During the 7 months we have worked together, she demonstrated high engagement and motivation. Besides, she had a key role in ensuring all regulatory aspects of clinical trials we were managing were kept following the GCP standards. María's greatest abilities are her capacity to learn quickly and her level of commitment to the job that she is developing. She is also enthusiastic and proactive so I definitely would recommend María.
Mayte Mejias Aranguren , BSC, MSC
Durante el tiempo que trabajamos en la misma compañía pude contagiarme de Maria de la excelente actitud y positividad. Siempre demostrando interés y responsabilidad en sus tareas y con una enorme empatía y respeto hacia los que le rodean.
Eduard Cabré Estivill, PhD
I worked with María Carranza in various clinical trials in the field of hemato-oncology at MFAR. María has effectively collaborated in analyzing and reporting results from clinical trials, performing remote monitoring visits, reporting safety events of investigation products, and ensuring the start-up documentation is ready for all centers participating in various clinical trials. During the 7 months we have worked together, she demonstrated high engagement and motivation. Besides, she had a key role in ensuring all regulatory aspects of clinical trials we were managing were kept following the GCP standards. María's greatest abilities are her capacity to learn quickly and her level of commitment to the job that she is developing. She is also enthusiastic and proactive so I definitely would recommend María.
Mayte Mejias Aranguren , BSC, MSC
Durante el tiempo que trabajamos en la misma compañía pude contagiarme de Maria de la excelente actitud y positividad. Siempre demostrando interés y responsabilidad en sus tareas y con una enorme empatía y respeto hacia los que le rodean.
Eduard Cabré Estivill, PhD
I worked with María Carranza in various clinical trials in the field of hemato-oncology at MFAR. María has effectively collaborated in analyzing and reporting results from clinical trials, performing remote monitoring visits, reporting safety events of investigation products, and ensuring the start-up documentation is ready for all centers participating in various clinical trials. During the 7 months we have worked together, she demonstrated high engagement and motivation. Besides, she had a key role in ensuring all regulatory aspects of clinical trials we were managing were kept following the GCP standards. María's greatest abilities are her capacity to learn quickly and her level of commitment to the job that she is developing. She is also enthusiastic and proactive so I definitely would recommend María.
Credentials
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CERF C1 certificate
British CouncilNov, 2019- Oct, 2024 -
ICH Good Clinical Practice
The Global Health NetworkAug, 2021- Oct, 2024
Experience
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IKF - Institute of Clinical Cancer Research
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Germany
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Research Services
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1 - 100 Employee
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Project Management Assistant/CRA
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Jul 2023 - Present
-Assistance with the initial submission of clinical studies and subsequent submission of protocol changes and notifications as well as preparation of required documents. -Preparation of study-specific documents for the conduct of clinical studies. -Preparation and mailing of study-specific Investigator Site Files or Pharmacy Folders. -Sending and following up on monitoring/follow-up emails to sites -Realisation of project-specific recruitment plans in close cooperation with the involved trial sites and the project manager. -Recording and processing of serious adverse events (SAE management) including support in the preparation of the annual safety report for submission to the authorities. -Logistics and review of incoming invoices from participating sites. -Creation and maintenance of study-specific electronic lists and folders. -Tracking of study-specific Summary of Product Characteristics/Investigator Brochure. -Manual data cleaning and query management. -Maintaining TMF creating and maintaining training lists for the completeness of TMF. -Sample management. -Support in the preparation, monitoring, and coordination of the conduct of multicenter studies in Spain and abroad. -Collaborating and communicating with participating sites, as well as coordinating and supporting them. -Improvement of and participation in the preparation of documents (e.g. SOPs) and further components of quality management. Show less
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Optimapharm
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Belgium
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Veterinary Services
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Clinical Research Associate III
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Apr 2023 - Jul 2023
Managing phase I and II clinical trials in Neurology, Oncology, Hematology, Endocrinology, and Medical Devices.•Independently Perform routine site visits, including pre-study, initiation, interim monitoring, and closeout visits.•Prepare accurate and timely trip reports.•Independently perform CRF review, query generation and resolution against established data review guidelines or data management systems as applicable.•Identify, document in writing, and adequately follow up with the site personnel and Client/Sponsor all protocol deviations, regulatory and GCP non-compliances, or any other issue involving the safety of the subjects.•Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution.•Undertake feasibility work when requested.•Recruitment and identification of potential investigators.•Preparation of EC submissions and notifications, translation of study-related documents (where applicable), organization of meetings, and other tasks as instructed by supervisor.•Negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable.•Administration of site payments in accordance with relevant project instructions.•Supporting sites with Serious Adverse Event (SAE) reporting, production of reports, narratives, and follow-up of SAE.•Participate in company-required training programs, timely and accurate completion as well as ongoing maintenance of Personal Training Records.•Host and/or participate in site quality visits, audits, and inspections, as applicable.•Assist with training of new employees.•Provide guidance to Clinical Trial Administrators (CTA).•Act as local client contact, as assigned.•Coordinate designated clinical projects as a Local Project Coordinator or Lead CRA (with supervision if applicable). Show less
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Clinical Research Associate II
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Nov 2021 - Apr 2023
Managing phase I and II clinical trials in Neurology, Oncology, Hematology, Endocrinology and Medical Devices.•Perform routine site visits including pre-study, initiation, interim monitoring and close out visits according to GCP ICH Guidelines and SOPs applicable (remote and/or onsite visits). •Prepare accurate and timely confirmation letters, trip reports and follow up letters.•Reviewing subject records, essential documents, investigational medical product disposition and accountability and other relevant study procedures.•Identify deficiencies and/or discrepancies related to source documents and Case Report Forms (CRFs) and working with the investigator and site personnel on resolution.•Independently perform CRF review, query generation and resolution against established data review guidelines or data management systems as applicable.•Maintain and continually update knowledge of protocol and amendments, applicable guidelines, manuals, Standard Operating Procedures (SOPs), conventions, tools, templates and instructions, as well as current GCP.•Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each individual CAPA until timely resolution.•Maintenance and management of the relevant project tracking systems as prescribed in the project plans.•With minimal supervision, negotiate study budgets with potential investigators/instructions and assist with execution of site contracts as applicable.•Maintain the study files and ensure that files are up-to date and accurate.•Supporting sites with SAEs reporting, production of reports, narratives and follow up of SAEs.•Participate in company-required training programs, timely and accurate completion as well as ongoing maintenance of Personal Training Record.•Host and/or participate in site quality control visit, audits and inspections, as applicable. Show less
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Alpha Bioresearch
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Spain
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Research Services
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1 - 100 Employee
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Clinical Research Associate I
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Feb 2021 - Nov 2021
Managing phase I, II and III clinical trials and observational studies in Onco-hematology, Cardiology, Neumology, and Neurology. • Performing site qualification, site initiation, monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, current legislation, company SOPs/processes and protocol compliance. •Performing confirmation letter, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. •Participation in national and international clinical trials. •Adaptation of HIP-CI to Spanish legislation. •Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. •Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. •Developing effective relationships with investigator site staff to ensure that key clinical metrics are met. •Preparing sponsor’s meetings and participation in global clinical monitoring/project staff meetings. •Performing monthly Newsletter and updating of weekly and monthly status. •Verifying required clinical data entered in the case report form (CRF) is accurate and complete ensuring data quality. •Opening and resolution of queries. •Opening and following of minor and major deviations from sites. •Performing investigational product inventory, reconciliation and reviews storage and security. •Samples delivery management. •Reporting of SAEs and SUSARs. •Following of payments to investigators. •Routinely reviews the Investigator Site File (ISF) and Trial Master File (TMF). •Participation in Start Up Unit and Regulatory procedures to submit clinical trials and observational studies. •Updating of production tables from different clinical trials. Show less
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MFAR, Marketing Farmacéutico & Investigación Clínica SL
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Research Associate
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Jul 2020 - Feb 2021
Managing phase II and III clinical trials and observational studies in Onco-hematology. Main tasks: -Communication with investigators and site management. -Support the study drug management. -Reporting of SAEs, follow-up and closure of SAEs and SUSARs. -Work in accordance with company SOPs, GCP guidelines and country specific regulations. -Develop, collect, review and edit clinical trial documentation. -Liaise and form positive working relationships with all colleagues, study site staff and sponsor representatives. -Responsible for TMF maintenance. Monitoring tasks: -Perform pre-study visits, Initiation, Monitoring & Close out visits, according to monitoring plan. -Source Data Verification (CRF against source documents). -Follow-up of CRF queries' resolution. -Track and report on progress of study including site activation, patient enrollment, monitoring visits, -Update of Study internal tables or control documents. Support tasks: -Support to CTA related to the distribution of new information (amendments, protocols, IB…). -Support of contracts management in start-up unit, documentation demanding to the sites (IP commintment, suitability of facilities, CVs, GCPs…). Show less
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Researcher Student
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Oct 2018 - Jul 2019
Experience in clinical laboratory management. Screening of drugs that inhibit RAS activity by SOS. Experience in clinical laboratory management. Screening of drugs that inhibit RAS activity by SOS.
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Intership Student
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Aug 2017 - Sep 2017
Curricular practices in the Hospital of Mérida, in the area of Molecular Genetics and Pathological Anatomy. Curricular practices in the Hospital of Mérida, in the area of Molecular Genetics and Pathological Anatomy.
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Education
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2019 - 2020
UNIR - La Universidad en Internet
Master's thesis in Clinical Trial Monitoring, Biomedicine -
2018 - 2019
Universidad de Salamanca
Master's thesis in Biology and Clinic of Cancer, Biomedicine -
2016 -
Universidad de Granada
Biotechnology, Sicue -
2014 - 2018
Universidad de Extremadura
Biotechnology, Biotecnología
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