Clinical Research Associate (CRA) - Cardiovascular (Remote)
$96,200–$151,400 year
On-siteMiami, Florida, United States or Fort Lauderdale, Florida, United States
Miami, Florida, United States or Fort Lauderdale, Florida, United StatesOn-siteFull Time$96,200–$151,400 yearEntry LevelEnterprise
Full TimeEntry LevelEnterprise
Job Summary
Monitor assigned sites and protocols ensuring compliance with ICH/GCP, local regulations, and study documents. Manage site relationships, coordinate site readiness, and conduct remote and on-site visits including initiation, monitoring, and close-out activities. Review regulatory documentation, communicate with investigators on protocol conduct and recruitment, and resolve performance or compliance issues through the defined escalation pathway. Support audit/inspection activities, manage data in CTMS and eTMF, and act as a subject matter expert for monitoring processes. Travel 65%-75% of working time domestically and internationally with a current driver's license required. Fluent in Spanish and English.
Required Qualifications
- Reside in South Florida (Ft. Lauderdale, Miami, Boca Raton, Key Largo)
- Fluent in Spanish
- Fluent in English (verbal and written)
- Current driver's license
- Associate's degree, certificate or equivalent in a scientific / healthcare discipline
- Bachelor's degree (or above)
- At least 5 years of relevant experience in the healthcare field
- At least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO
- 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)
- Ability to understand and analyze data/metrics and act appropriately
- Capable of managing complex issues, works in a solution-oriented manner
- Effective time management
- Organizational and interpersonal skills
- Conflict management
- Problem solving skills
- Ability 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
- Commitment to Customer focus
- High quality and compliance mind-set
- Positive mindset
- Growth mindset
- Capable of working independently and being self-driven
- Professional demeanor and communication consistent with organizational policies and practices
- Ability to perform root cause analysis and implement preventative and corrective action
- Ability to travel domestically and internationally approximately 65%-75% of working time
- Expected travelling ~2-3 days/week
- 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
Desired Qualifications
- Master's degree preferred
- Experience with Adverse Event Reporting System preferred
- Experience with Clinical Site Management preferred
- Experience with Clinical Study Management preferred
- Experience with Clinical Trial Planning preferred
- Experience with Clinical Trials preferred
- Experience with Clinical Trials Monitoring preferred
- Experience with Data Analysis preferred
- Experience with Data Reporting preferred
- Experience with Early Clinical Development preferred
- Experience with Good Clinical Data Management Practice (GCDMP) preferred
- Experience with Pharmacovigilance preferred
- Experience with Preventive Action preferred
- Experience with Protocol Adherence preferred
- Experience with Regulatory Affairs Compliance preferred
- Experience with Regulatory Compliance preferred
- Experience with Site Management preferred
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