Jessica Ponce Malagón Clinical Research Associate II

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Clinical Research Associate (CRA) / Clinical Operations Specialist

Hospitals, IQVIA

Mar 2023 - Feb 2024 (1 year)

• Coordinated communication between investigators, study coordinators, and sponsors in English and Spanish, ensuring seamless information flow. • Explained protocols, procedures, and regulatory requirements to clinical site staff, fostering understanding and adherence to Good Clinical Practice (GCP). • Reviewed patient data and source documents, identifying discrepancies and ensuring compliance with established clinical practices. • Supported patient-facing processes, providing clear and accessible information to enhance patient understanding and engagement. • Leveraged expertise in CRM tools and digital systems management, adapted for clinical trial data collection and analysis, to gather comprehensive trial information and ensure data int

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Medical Interpreter

LINGUISTICA INTERNATIONAL,

Sep 2019 - May 2021 (1 year 9 months)

• Provided English–Spanish interpretation for patients, healthcare staff, and administrative personnel. • Ensured accurate, neutral, and culturally appropriate communication in medical, administrative, and insurance contexts. • Assisted with telehealth appointments, discharge instructions, medication explanations, and informed consent discussions. • Managed high-volume sessions while maintaining professionalism and confidentiality.

Clinical Research Associate

Syneos Health, Novartis

Sep 2016 - Aug 2017 (1 year)

Phase IV protocol. Selection of 10 investigational sites and follow-up on submissions and approvals from COFEPRIS. Organization of Investigator Meeting, site personnel training, Site Initiation Visits, Monitoring of Informed Consent process, diaries completion (paper and electronic), Adverse Event reporting to COFEPRIS and local Ethics Committees, follow-up visits, queries creation and resolution, subject binders review during monitoring visits as well as site regulatory binder. To provide support to the sites for Investigational Product availability in the market with the sales force and Medical Manager.

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Clinical Research Associate II

ICON Clinical Research México, ICON Clinical Research

Oct 2014 - Apr 2016 (1 year 7 months)

conducted monitoring visits for Phase III and IIIB studies on biopharmaceutical drugs for osteoporosis and cardiovascular diseases in Mexico and Guatemala. Monitoring studies, training site personnel in GCPs and protocols, and managing Investigational Product accountability. I performed both remote and on-site monitoring, including pre-visit reports, database checks, and regulatory binder reviews. Additionally, I ensured cold chain management, prepared new sites, submitted regulatory documents, and followed up with vendors, investigator payments, and adverse event reporting. I also reviewed Informed Consent Forms and ensured compliance with the sponsor metrics to improve site performance.

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Clinical Research Associate

La Red (Red Mexicana de Investigación Clínica en Enfermedades Infecciosas Emergentes)

Sep 2013 - Sep 2014 (1 year 1 month)

This collaboration between the National Institutes of Health (USA) and the National Institutes of Health (Institutos Nacionales de Salud) in Mexico, focused on respiratory diseases (like influenza). Responsibilities included coordinating local study activities, conducting Site Initiation Visits, monitoring clinical trials per GCPs, preparing dossiers for COFEPRIS, collecting and filing essential study documentation, and performing interim monitoring visits. Tasks also involved completing Monitoring Visit Reports, resolving queries, reporting data, preparing AE/SAE reports, and maintaining communication with the sponsors, investigators, and Ethics Committees. Additionally, it was crucial to maintain strong relationships with Principal Invest

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Clinical Research Associate

Accelerated Clinical Research

May 2011 - May 2013 (2 years 1 month)

This company is entirely dedicated to doing Clinical Research with devices (no medications). The role involves researching and analyzing potential investigators and sites, conducting interviews, and screening suitable candidates. Responsibilities include ensuring coherence between the Protocol, Informed Consent, CRFs, and related documents. Clinical coordination covers activities like Site Initiation Visits, training, monitoring clinical trials per GCPs, and preparing dossiers for Ethics Committees, the Ministry of Health (COFEPRIS), and other regulatory bodies. Additional tasks include collecting and filing study documentation, conducting interim monitoring visits, creating queries, supporting query resolution, entering data into study dat

Jessica Ponce Malagón

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