Clinical Research Associate

MSD Malaysia; Partido de Vicente López; Hybrid; ARS 900,000 - 1,300,000; Full time

Job summary

MSD Malaysia is seeking a Clinical Research Associate to manage clinical study sites in Argentina, ensuring compliance with ICH-GCP, sponsor SOPs, local regulations and quality standards. The role includes site visits, regulatory documentation, and collaboration with investigators to drive site performance.

Ideal candidates will have at least 2 years of direct monitoring experience, strong biology background, and fluent English.

Qualifications

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

Responsibilities

• Develop strong site relationships and ensure continuity through all trial phases.
• Perform site management/monitoring activities in compliance with ICH-GCP and local laws.
• Coordinate tasks with sponsor roles to achieve Site Ready and participate in site selection/validation.

Skills

Fluent English

Site Management

Monitoring Visits

ICH/GCP Knowledge

Data Analysis

MS Office

Education

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

Tools

CTMS

eTMF

GCDMP

Job description

Job Description 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.

• 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

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

Required Skills

Accountability, Accountability, Adaptability, Adverse Event Reporting System, Adverse Events, Business Activity Monitoring, Clinical Reporting, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Monitoring, Data Reporting, Document Management, Electronic Trial Master File, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Meeting Facilitation, On Site Management, Protocol Adherence, Protocol Development, Protocol Review {+ 7 more}

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): no