Jessica Alejandra Mateos Rodríguez

- In charge of performing site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and protocol compliance.

- Used to employ judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicating serious issues to the project team and developing action plans.

- Ongoing verification that the process of obtaining informed consent has been adequately performed and documented for each subject as required.

- Demonstrates diligence in protecting the confidentiality of each subject.

- Assesses factors that might affect subjects' safety and clinical data integrity at an investigator site such as protocol deviation/violations and pharmacovigilance issues.

- Verifies issues or risks associated with blinded or randomized information related to the Investigational Product.

- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labelled, received, monitored, returned and destroyed if applicable.

- Routinely reviews the investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciling contents of the ISF with the Trial Master File (TMF) and ensuring the site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

- Documents activities via confirmation letters, follow-up letters, trip reports, and other required project documents as per SOPs and Clinical Monitoring Plan.

- Supports subject recruitment, retention and awareness strategies

• In charge of monitoring visits and site management for a variety of protocols, sites throughout Mexico and therapeutic areas.
• Mentoring of new and unexperienced clinical staff.
• CRAs supervision as leader on big studies and issues escalation as applicable.
• Collaboration and assistance with study team members for project execution support as appropriate (i.e., with the clinical team managers and project managers for study tools, documents, study processes improvement and development).
• Mentoring of Junior CRAs on role knowledge, processes, systems guidance and best practices to be followed.
• In depth knowledge and application of clinical research regulatory requirements; i.e., GCP and ICH guidelines.
• In depth therapeutic and protocol knowledge as assigned by company.
• Strong written and verbal communication skills including excellent management of English language.
• Strong time management skills.
• Ability to manage multiple priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Extensive use of telephone and face-to-face communication requiring an accurate speech.
• FDA Audit preparation, May2022.
• Investigator Meeting Assistance, Atlanta, USA, Sep2022.
• Management of sites with more than 130 subjects.
• Management of pediatric studies.

• Perform onsite and remote monitoring visits and follow-up (initiation, monitoring and close-out visits) according to scope of work and regulatory requirements. Ensuring full source data verification and review is done according to client monitoring requirements in both adult and pediatric populations, small or big trials and maintaining a strict investigational product overview.
• Work with sites to adapt, drive and track subjects recruitment.
• Administer protocol and related study training to assigned sites and establish and maintain good and constant lines of communication with sites to manage project expectations and issues resolution.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalation of quality issues when appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion, submission, and data query generation, follow up and resolution. Support on start-up phase as required.
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain complete and correct documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

• Team leader for CTC-Cs mexican team on the Moderna COVID-19 vaccine project from May2020 to Dec2020.
• Administration for start-up, ongoing and close-out ready studies; creation, reconciliation and filing of study-specific documents (such as the Protocol, IB, ICFs, patient materials, study newsletters, study metrics, logs, team lists, study FAQs, directives, etc.).
• Meeting minutes creation and distribution, study metrics reports delivery, clinical systems access management.
• Global, Country and Site level audit preparation of the clinical systems documents and vendors trackers maintenance.
• Client meetings scheduling, purchase orders requests, clinical project-specific training management.
• Team meetings coordination, tasks planning and assignation; new staff members mentoring.

• Principal activities: project and experimental protocol design, cell cultures, amplification and titration of Dengue virus, protein quantification, differential ultracentrifugation, flow cytometry, transmission electron microscopy, sucrose and Iodixanol (OptiPrep) gradients, nanoparticle tracking analysis (NanoSight), purification and quantification of RNA, RT-PCR, electrophoresis.

• Principal activities: clinical study design, clinical file review, peripheral venous blood sampling, Ficoll PBMCs extraction, cell counting and culture, ELISAs.

• Principal activities: MCF-7 mammary carcinoma cell line cultures, protein extraction, protein quantification by the Bradford method, Western Blot, densitometry.

• Principal activities: brain implant surgeries in Wistar rats, sleep record analysis.