Senior Clinical Research Associate

MSD LATAM; Santiago; Híbrido; CLP 36.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

MSD LATAM in Chile is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee the performance, quality, and compliance of trial sites and protocols.

You will be the primary contact for investigators and site staff, guiding site activities through the study lifecycle. You will work with cross-functional teams to ensure data quality, patient safety, and regulatory compliance, while mentoring junior CRAs and identifying new site opportunities.

Formación

• Bachelor’s degree or higher required.
• At least 4 years of direct site management (monitoring) experience in pharma, biotech, or CRO.
• Strong communication, problem-solving, and organizational skills; ability to work independently.
• Domestic and international travel up to 65-75% may be required.

Responsabilidades

• Site selection, start-up, monitoring, regulatory document management and issue resolution.
• Data quality oversight and patient safety protection throughout the study lifecycle.
• Collaborate with cross-functional teams and stakeholders to support study execution.
• Mentor junior CRAs and identify new site opportunities; support audits and inspections.

Conocimientos

Site monitoring

Site management

Communication skills

Problem-solving

Organizational skills

Independent work

Mentoring junior CRAs

Cross-functional collaboration

Audit support

Site start-up & close-out

Regulatory document management

Patient safety awareness

Study lifecycle oversight

Educación

Bachelor’s degree or higher

Descripción del empleo

Senior Clinical Research Associate (Sr. CRA)

The Senior Clinical Research Associate is responsible for the performance, quality, and compliance of assigned clinical trial sites and protocols within the country. Acting as the primary point of contact for investigators and site staff, the Sr. CRA oversees site activities throughout the study lifecycle, ensuring adherence to ICH-GCP, local regulations, and company standards.

Responsibilities

• Site selection, start-up, monitoring, regulatory document management, issue resolution, data quality oversight, patient safety protection, and site close-out activities.
• The role collaborates closely with cross-functional teams and external stakeholders to support successful study execution while driving site performance, recruitment, and operational excellence.
• The Sr. CRA also serves as a subject matter expert, sharing best practices, supporting audits and inspections, mentoring junior CRAs, and identifying new site opportunities to strengthen clinical research capabilities.

Qualifications

• Candidates must hold a Bachelor’s degree (or higher) and;
• Have at least 4 years of direct site management (monitoring) experience in a pharmaceutical, biotechnology, or CRO environment.
• Strong communication, problem-solving, and organizational skills are essential, along with the ability to work independently in a dynamic environment.
• Domestic and international travel of up to 65-75% may be required

Required Skills

• Accountability, Accountability, Adaptability, Adverse Event Report, Clinical Data Management, Clinical Development, Clinical Reporting, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Study Management, Clinical Trial Compliance, Clinical Trial Development, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Customer Auditing, Customer-Focused, Drug Development, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Government Regulation, Industry Regulation, Legal Compliance, Liaison Work

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date

10/1/2026

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