Cristopher Escamilla Email & Phone Number

Barcelona, Ct, Es

España

• Country management for clinical studies Phase I – II with T-Cell therapy• Independent and proactive co-ordination of clinical research/project monitoring and monitoring related activities• Preparation of Contract of the Performance of Clinical Trials• Contract negotiation with sites• Preparation of Investigational Medicinal Product release• Managing translation and QC of study documents• Conducting Monitoring Visits: Pre-SIV, Site Initiation Visits, Site Monitoring Visit• Conducting GCP monitoring visits in accordance with applicable SOPs/SSPs• Preparation and delivery of Monitoring Visit Reports• Country CTM• Supervising and evaluation CRAs performance• Developing training material• Coordinating co-monitoring visits and quality visits• Study relationship with KoL in Spain• Resolving issues (IP release, recruitment improvement, eCRF confection)

Barcelona, Cataluña, España

OVERALL RESPONSIBILITIES:• To ensure the Principal Investigator, the clinical staff and the (physical) site meet all requirements to conduct a clinical trial under an Investigational New Drug Application (IND).• To ensure that the study is being conducted in compliance with the protocol, the SOPs, ICH-GCP, US CFR and local regulations• To ensure the integrity of the data; that documentation is present, complete and in compliance with ICH-GCP, applicable US Codes of Federal Regulations (CFRs) and local regulations• To ensure that participants meet eligibility criteria, including a signed informed consent document• To ensure that the Investigational Products or Medical Devices are handled in accordance with investigational product procedures provided by the Sponsor, and accountability is accurately documented• To ensure that site’s study documents are in place, updated and stored appropriately• To ensure the safety and well-being of study volunteers is being prioritized and that precautions are in place to minimize risk.

España

• Conducting Monitoring Visits: Pre-SIV, Site Initiation Visits, Site Monitoring Visit• Conducting GCP monitoring visits in accordance with applicable SOPs/SSPs• Preparation and delivery of Monitoring Visit Reports• Participate in monthly study meeting• Assisting Project Manager• General site support• Complete reports in a timely manner. • Work collaboratively with investigative sites to develop strong, long-term, working relationships. • Apply Standard Operating Procedures (SOPs), Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.

Madrid, Comunidad De Madrid, España

 Act as liaison between the in-house team, vendors, and multiple clinical sites. Work collaboratively with investigative sites to develop strong, long-term, working relationships. Apply SOPs, MP, study manuals and other materials and guidelines as applicable. Help identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with start-up activities Perform Site Initiation Visits. Perform Interim Monitoring Visits for assigned studies:o Monitor site compliance with study protocol and GCP.o Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents.o Ensure the site is entering data according to the CRF Completion Guidelines.o Perform drug accountability and ensure adequate drug supply.o Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required. Assist study team.o Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.o Monitor site compliance with IRB policies/processes and ensure timely submissions and approvals.Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance. Perform Close Out visits as assigned. Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined inthe CPM. Track, report, and follow all action items to resolution. Maintain CTMS in a timely fashion, utilizing available reports and study tools. Assist data management. Provide co-monitoring support. Contribute to the preparation and follow-up of on-site Client sponsored quality audits and regulatory authority inspections as assigned. Discuss scientific, medical and therapeutic area information. May have opportunities to contribute to other clinical trial related activities, including vendor management, data review, or other study-related activities.

España

• Independent and proactive co-ordination of clinical research/project monitoring and monitoring related activities• Preparation of Contract of the Performance of Clinical Trials• Contract negotiation with sites • Preparation of Investigational Medicinal Product release• Managing translation and QC of study documents • Conducting Monitoring Visits: Pre-SIV, Site Initiation Visits, Site Monitoring Visit• Conducting GCP monitoring visits in accordance with applicable SOPs/SSPs• Preparation and delivery of Monitoring Visit Reports• Participate in monthly study meeting• Assisting Project Manager• General site support• Escalating Signiant non-compliance issues

Barcelona, Spain.

OVERALL RESPONSIBILITIES:• To ensure the Principal Investigator, the clinical staff and the (physical) site meet all requirements to conduct a clinical trial under an Investigational New Drug Application (IND).• To ensure that the study is being conducted in compliance with the protocol, the SOPs, ICH-GCP, US CFR and local regulations• To ensure the integrity of the data; that documentation is present, complete and in compliance with ICH-GCP, applicable US Codes of Federal Regulations (CFRs) and local regulations• To ensure that participants meet eligibility criteria, including a signed informed consent document• To ensure that the Investigational Products or Medical Devices are handled in accordance with investigational product procedures provided by the Sponsor, and accountability is accurately documented• To ensure that site’s study documents are in place, updated and stored appropriately• To ensure the safety and well-being of study volunteers is being prioritized and that precautions are in place to minimize risk.

Madrid Y Alrededores, España

• Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.• Site management responsibility for clinical studies.• Assures the implementation of project plans as assigned.• Function as leader for projects of limited scope as assigned.• Assume line management responsibilities as assigned.• Act in the project sole of Local Project Coordinator or Lead CRA as assigned.

Freelance

• Evaluation of clinical trials under local regulations.• Ensure compliance with GCP and ICH recommendations.• Authoring FDA criteria.

Barcelona, Spain.

- To manage CRA resources and activities to ensure efficiency and quality in clinical trials.- Having well trained personnel and focusing on continuous improvement of processes and people.- To ensure operational feasibility in protocols written at SOLTI.- To assess the performance of CRAs.- Preparing and following-up departmental annual budget.- To propose and lead innovative initiatives for improvement of departmental processes.

Experience in clinical trials (phases I, II, III, IV) with international projects and interdisciplinary work teams.• Management of CRA Jrs.• Perform site initiation, monitoring visits, close visit.• Complete reports in a timely manner.• Mastery of various therapeutic areas, like rheumatology, oncology, neuroscience,dermatology, ophthalmology, and others.• Maintain strong relations with investigators and sponsor.• Manage and ensure the good progress of the trials process.• Evaluate and maintain the dedicated timelines.

Freelance

• I performed the statistical of clinical trial, with analyses of efficacy, safety and quality of life in phase III-IV.• Drafting and submission of the final statistical report of clinical trials.• Performing the interim statistical analysis of clinical trials phase I-II.• Validation captures databases. Verification of databases.

• I performed the statistical of clinical trial, with analyses of efficacy, safety and quality of life in phase III-IV.• Drafting and submission of the final statistical report of clinical trials.• Performing the interim statistical analysis of clinical trials phase I-II.• Validation captures databases. Verification of databases.

• Perform site initiation, monitoring visits, close visit.• Get sponsors projects to implement clinical trials.• Create partnerships with research centers.• Design of standard procedures in the creation of a CRO.• Recruitment.• Communications with universities and health ministry.

• Translational medical advice to clinical studies phase I.• Scientific feasibility.• Health security consulting.• Give talks on various health issues, such as tumor markers, mananging syncope, etc.

Master Of Neruciences, Medicina

Bachelor Of Medicine, Bachelor Of Surgery (M.B.B.S.), Medicina