Senior Clinical Research Associate – Cardiovascular, Bilingual English/Spanish

MSD

. Ensure performance and compliance for assigned clinical trial protocols and sites .

Posted 10/16/2026full-timeRemote • United States, Puerto RicoSenior💰 $129,000 - $203,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, ensuring compliance with GCP/ICH guidelines and effective site performance. Proficient in mentoring, data analysis, and maintaining strong relationships with clinical research sites while managing complex issues.

Highest-signal resume keywords

Clinical Trial ManagementSite Management ExperienceFluent Spanish Speaking SkillsGood Clinical Practice (GCP)Data Analysis and Metrics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite MonitoringRegulatory DocumentationGood Documentation PracticesPatient RecruitmentRoot Cause AnalysisQuality ControlClinical Trial PhasesClinical IT ApplicationsData Metrics Analysis

Soft Skills

Interpersonal SkillsTime ManagementProblem-SolvingConflict ManagementOrganizational Skills

Tools & Technologies

CTMSETMFMS Office

Industry Keywords

BioPharmaCROClinical Research GuidelinesClinical Operations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure performance and compliance for assigned clinical trial protocols and sites
Act as primary site contact and site manager throughout all phases of clinical research studies
Develop and maintain strong site relationships
Perform remote and on-site monitoring and oversight activities
Conduct validation, initiation, monitoring, and close-out visits
Ensure data are complete, accurate, and unbiased and protect subjects’ rights, safety, and well-being
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and site performance
Identify, assess, resolve, and escalate site performance, quality, and compliance issues
Collaborate with internal clinical operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters teams, vendors, IRBs/IECs, and regulatory authorities
Manage documentation and information in CTMS, eTMF, and other systems
Act as a process SME, share best practices, recommend improvements, and provide training
Support or lead audit and inspection activities
Identify and develop potential new clinical research sites
Mentor junior CRAs and perform co-monitoring visits
Perform quality control visits when delegated and appropriately trained

Requirements

What you’ll need

Fluent Spanish speaking skills required
Fluent in local languages and English, verbal and written
Associate’s degree, certificate or equivalent in a scientific / healthcare discipline with at least 7 years of relevant healthcare experience, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO; or Bachelor’s degree or above with at least 4 years of direct site management experience in a bio / pharma / CRO
Excellent understanding of clinical research, clinical trial phases, current GCP/ICH, and country clinical research laws and guidelines
Excellent understanding of global, country/regional clinical research guidelines
Demonstrated ability to mentor/lead
Hands-on knowledge of Good Documentation Practices
Proven site management skills, including independent management of site performance and patient recruitment
Demonstrated monitoring skills with independent professional judgment
Good IT skills, including MS Office and clinical IT applications
Ability to understand and analyze data/metrics and act appropriately in a virtual environment
Experience conducting site motivational visits to boost site enrollment
Ability to manage complex issues and perform root cause analysis and corrective/preventive action
Effective time management, organizational, interpersonal, conflict management, problem-solving, and multitasking skills
Ability to work independently across multiple protocols, sites, and therapy areas
Ability to work effectively in a matrix multicultural environment
Current driver’s license required
Ability to travel domestically and internationally approximately 65%-75% of working time

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Remote work arrangement
No relocation required