Marta Lalinde Email & Phone Number

Madrid, Es

Zaragoza, Aragón, España

Clinical Trials - Hematology and Pediatric Oncology Units- Track enrollment status of subjects.- Create and/or maintain all documents and records related to the study.- Direct the requisition, collection, labeling, storage, or shipment of specimens.- Interpret protocols and advise physicians on modifications based on patient characteristics.- Advise the principal investigator in decision making and selection of patients, following the protocol criteria.- Train and mentor other members of the research team, fostering an environment of learning and professional development.- Attend, conduct and participate in Site Initiation, Monitoring and Close Out Visits.- Document patient data on case report forms (CRFs) and source documents at each study visit.- Submit accurate data for computer tracking.- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.- Maintain contact with sponsors to schedule and coordinate.- Manage the inventory of equipment and supplies related to the study and order more as needed.- Attend and participate in investigator meetings, seminars, and other regional or national research meetings.- Maintain required records of study activity including CRFs, drug dispensation records, or regulatory forms.

Madrid, Comunidad De Madrid, España

Perform monitoring and site management activities for Phase I-IV clinical research projects.- Assess the progress of clinical projects at assigned investigative/physician sites (site or remotely).- Ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.- Conduct Source Document Review of appropriate site source documents and medical records.- Verify required clinical data entered in the case report form (CRF) are accurate and complete.- Apply query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.- Perform investigational product (IP) inventory, reconciliation and reviews storage and security.- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.- Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

Zaragoza, Aragón, España

Clinical Trials - Adult Oncology Unit

Zaragoza, Aragón, España

Zaragoza, España

Bachelor Thesis: “Combination of advanced therapies and nanotechnology against cancer” (Biotechnology - URV)

Zaragoza, España

Programa Abierto De Especialización En Project Management En Investigación Clínica

Bachelor'S Degree, Biotechnology

Master'S Degree In Clinical Trials Monitoring And Pharmaceutical Development

Expert Master'S Degree, Fertility And Assisted Human Reproduction