Clinical Research Associate

MSD LATAM; Tandil; Hybrid; ARS 90,873,000 - 136,310,000; Full time

Job summary

MSD LATAM is seeking a Clinical Research Associate to manage sites across Argentina, ensuring ICH-GCP compliance and high-quality data across monitored sites. You will build site relationships, conduct on-site and remote monitoring, and oversee regulatory documentation with cross-functional teams.

The role emphasizes strong English communication, adherence to SOPs, and collaboration with CRA managers to expand site networks and ensure trial readiness in multiple Argentine sites.

Qualifications

• 2 years of direct site management (monitoring) experience in bio/pharma/CRO (min 1 year).
• Fluent in English (verbal and written).
• B.A./B.S. with strong emphasis in science and/or biology.

Responsibilities

• Develops and maintains strong site relationships across all trial phases.
• Performs site management/monitoring per ICH-GCP, SOPs, laws and regulations.
• Gains deep understanding of study protocol and procedures.
• Coordinates tasks with sponsor roles to achieve Site Ready.
• Participates in site selection and validation activities.
• Performs remote and on-site monitoring with appropriate tools.
• Ensures data completeness, accuracy and unbiased reporting.
• Protects subjects’ rights, safety and well-being.
• Manages regulatory docs for start-up, maintenance and close-out.
• Communicates with investigators and staff on protocol issues and audits.
• Identifies and escalates performance/quality issues per CRA pathways.
• Maintains information in CTMS/eTMF and other systems.
• Shares SME knowledge and mentors others; supports audits/inspections.
• Contributes to site development under country strategy.

Skills

Site management

Monitoring

Clinical research

GCP knowledge

Data analysis

MS Office

Multitasking

Communication

Problem solving

Education

B.A./B.S. in science/biology

Tools

CTMS

eTMF

Job description

Possible locations Buenos AIres - Mar del Plata - Córdoba - Rosario. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Job Description

Possible locations Buenos AIres - Mar del Plata - Córdoba - Rosario. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The role is accountable for performance and compliance for assigned protocols and sites in Argentina. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expand the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Main Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure
• Data generated at site are complete, accurate and unbiased
• Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and RCPM.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities

Core Competency Expectations

• Fluent in English (verbal and written) and 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 analyse data/metrics and act appropriately
• Behavioural 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 high quality and compliance mind-set

Requirements

• 2 years of direct site management (monitoring) experience in a bio/pharma/CRO (minimun 1 year).
• Fluent in English (verbal and written)
• B.A./B.S. with strong emphasis in science and/or biology

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Required Skills

Accountability, Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Conflict Management, Cultural Awareness, Customer Centricity, Customer-Focused, Data Analysis, Data Reporting, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset, Lateral Thinking, Matrix Management, Multitasking, Problem Identification {+ 6 more}

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

no

Job Posting End Date

11/7/2026