Clinical Research Associate

Caraway Therapeutics, Inc.; Buenos Aires; Hybrid; ARS 138,487,000 - 184,649,000; Full time

Benefits offered by this job

Hybrid work model

Competitive rewards program

Job summary

Caraway Therapeutics, Inc. in Argentina is seeking a Clinical Research Associate to manage and monitor study sites, ensuring ICH-GCP compliance and effective site operations. You will oversee site performance, regulatory documentation, and collaboration across sponsor teams to advance trials in the region.

The role requires 2 years of direct site management experience, fluent English, and a BA/BS in science or biology. Hybrid work arrangements are available and travel may be required.

Qualifications

• 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

• Develops and maintains strong site relationships across all trial phases.
• Performs site management/monitoring in line with ICH-GCP and SOPs.
• Gains understanding of study protocol and related procedures.
• Coordinates tasks with sponsor roles to achieve Site Ready.
• Participates in site selection and validation activities.
• Performs remote and on-site monitoring with approved tools.
• Ensures data quality, subject safety, and timely visit reports.
• Manages regulatory docs for start-up, maintenance and close-out.
• Communicates with Investigators on protocol conduct and site performance.
• Identifies and resolves site performance/compliance issues with escalation.
• Manages information in CTMS/eTMF and other systems.
• Contributes as SME and mentors teammates; supports audits/inspections.

Skills

Site management

Monitoring

Data analysis

Communication skills

English

Education

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

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.
• 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.

Additional location(s) Compensation Information

• 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}

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:
11/22/2026
*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.