Spclst, Clinical Research Associate

Merck Gruppe - MSD Sharp & Dohme; Ciudad de México; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

Una empresa innovadora busca un Asociado de Investigación Clínica (CRA) para garantizar el cumplimiento y el rendimiento de los protocolos. En esta emocionante posición, serás responsable de gestionar relaciones con los sitios, realizar visitas y asegurar que se cumplan las normativas y procedimientos. Tu papel será fundamental para mejorar los tiempos de ciclo y cumplir con los compromisos de inscripción en los estudios. Si tienes una mentalidad proactiva y habilidades en gestión de sitios, esta es tu oportunidad de contribuir a investigaciones que impactan la salud global.

Formación

• Mínimo 2 años de experiencia en gestión de sitios en bio/farma/CRO.
• Conocimientos sólidos en investigación clínica y regulaciones locales.

Responsabilidades

• Desarrollar relaciones sólidas con los sitios a lo largo de todas las fases del ensayo.
• Realizar actividades de gestión y monitoreo de sitios de estudio clínico.

Conocimientos

Gestión de sitios

Conocimientos de GCP/ICH

Comunicación efectiva

Análisis de datos

Resolución de problemas

Habilidades informáticas

Educación

Disciplina científica o de salud

Herramientas

MS Office

Aplicaciones clínicas IT

Descripción del empleo

Job Description

Join Our Team as a Clinical Research Associate (CRA)!

The Clinical Research Associate (CRA) plays a critical role to ensure performance and compliance for our company Protocols. Under the guidance of the Country Research Manager (CRM) / Line Manager (LM), you will be responsible for ensuring country regulations, our company policies and protocol procedures are fulfilled in a timely manner throughout all phases of clinical research study.

Your contributions will be key in meeting study enrollment commitments and improving cycle times, including developing a strong collaboration with the Clinical Operations Manager (COM), Therapeutic Area Lead (TAH), and Clinical Research Manager (CRM). In addition, you will partner with regulatory, supplies, finance, and site staff to efficiently manage operations.

Responsibilities include, but are not limited to:

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

Extent of Travel

• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travel 2-3 days/week.

CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) with excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands-on knowledge of Good Documentation Practices.
• Proven skills in Site Management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS Office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyze data/metrics and act appropriately.
• Perform root cause analysis and implement preventive and corrective action.

Behavioral Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
• Able to work highly independently across multiple protocols, sites, and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to customer focus.
• Works with a high quality and compliance mindset.
• Positive mindset, growth mindset, capable of working independently and being self-driven.

Experience Requirements:

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

• Preferred Scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/31/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R342995