Clinical Research Associate (CRA) - Cardiovascular (Remote)

MSD • Miami Beach, FL

1d • $96,200 - $151,400 • Remote

About The Position

The Clinical Research Associate (CRA) - Cardiovascular role is responsible for ensuring the performance and compliance of assigned clinical research protocols and sites within a specific country. Reporting to the CRA-Manager, the CRA ensures that study conduct adheres to ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements. This role serves as the primary contact and manager for allocated study sites throughout all phases of a clinical research study. Additionally, the CRA is responsible for actively developing and expanding the territory by identifying and cultivating new research sites. The position also involves participating in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.

Requirements

• Must reside in South Florida (Ft. Lauderdale, Miami, Boca Raton, Key Largo).
• Fluent in Spanish and English (verbal and written).
• 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.
• Ability to understand and analyze data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Effective time management, organizational, and interpersonal skills.
• Conflict management and 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 a high-quality and compliance mindset.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
• Current driver’s license required.
• Associate's degree, certificate, or equivalent in a scientific/healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• OR Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• Adaptability
• Adverse Event Reporting System
• Clinical Research Methods
• Clinical Site Management
• Clinical Study Management
• Clinical Trial Planning
• Clinical Trials
• Clinical Trials Monitoring
• Data Analysis
• Data Reporting
• Early Clinical Development
• Good Clinical Data Management Practice (GCDMP)
• Pharmacovigilance
• Preventive Action
• Protocol Adherence
• Regulatory Affairs Compliance
• Regulatory Compliance
• Site Management

Nice To Haves

• Ability to travel domestically and internationally approximately 65%-75% of working time.
• Expected travelling ~2-3 days/week.

Responsibilities

• Develops strong site relationships and ensures continuity 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates and provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring and oversight activities using various tools to ensure data accuracy, subject protection, and compliance.
• Conducts site visits (validation, initiation, monitoring, close-out) and records clear, comprehensive, and accurate reports in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, maintenance, and close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and site performance.
• Identifies, assesses, and resolves site performance, quality, or compliance problems, escalating as appropriate in collaboration with management.
• Works in partnership with various internal departments (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external entities (vendors, IRB/IECs, Regulatory Authorities) to support assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF, and other systems per timelines.
• Contributes to CRA team knowledge by acting as a process SME, buddy/mentor, and sharing best practices.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities, following country strategy.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree