Sr. CRA – Clinical Research Associate

About This Opportunity

We are representing a confidential pharmaceutical organization seeking a Senior Clinical Research Associate to join their Puerto Rico operations. This is a remote position requiring significant travel (75%) to clinical trial sites. Our client is a global leader in drug development, and this role offers direct impact on life-changing research initiatives.

Responsibilities

As a Senior CRA, you will:

• Develop and maintain strong relationships with clinical trial sites throughout all phases of studies
• Perform site management and monitoring activities in full compliance with ICH-GCP, SOPs, local regulations, and study protocols
• Conduct remote and on-site monitoring visits including validation, initiation, monitoring, and close-out visits
• Ensure data generated at sites is complete, accurate, and unbiased while protecting subject rights, safety, and well-being
• Coordinate site readiness activities and provide input on site selection and validation
• 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, and overall performance
• Identify, assess, and resolve site performance, quality, or compliance issues with appropriate escalation
• Maintain documentation in CTMS, eTMF, and other clinical trial management systems
• Mentor junior CRAs and perform co-monitoring visits as needed
• Support audit and inspection activities
• Contribute to continuous improvement initiatives and serve as a process subject matter expert

What We're Looking For

Required Education and Experience:

• Bachelor's degree (or higher) with at least 4 years of direct site management/monitoring experience in biopharma or CRO
• OR 7 years of relevant healthcare experience including at least 4 years of direct monitoring experience

Core Competencies:

• Fluency in local languages and English (verbal and written) with excellent communication skills
• Excellent understanding of clinical research, trial phases, current GCP/ICH guidelines, and local clinical research regulations
• Proven site management skills including independent oversight of site performance and patient recruitment
• Demonstrated high-level monitoring skills with independent professional judgment
• Experience mentoring and leading junior team members
• Strong IT skills across multiple platforms (MS Office, clinical applications on computer, tablet, and mobile devices)
• Ability to analyze data and metrics and take appropriate action in virtual environments
• Experience conducting site motivational visits to boost enrollment
• Capability to perform root cause analysis and implement corrective actions

Behavioral Competencies:

• Strong commitment to customer focus and quality/compliance mindset
• Effective time management, organizational, and interpersonal skills
• Ability to work independently across multiple protocols, sites, and therapy areas
• High sense of accountability and urgency with excellent prioritization skills
• Effective collaboration in matrix, multicultural environments
• Growth mindset with self-driven work style
• Professional demeanor consistent with organizational standards

Additional Requirements:

• 75% travel required to clinical sites
• Valid driving license required
• Remote work arrangement with home-based office setup

How We Work With You

Get A Job.ai represents top-tier pharmaceutical and biotech organizations seeking exceptional clinical research talent. When you apply through our platform, here's what happens:

• You submit your application directly through getajob.ai
• Our specialized recruiting team reviews your qualifications and conducts an initial screening
• Qualified candidates are presented to our client with full preparation and advocacy
• We guide you through each stage of the interview process
• Please do not contact the employer directly, as this is a confidential search managed exclusively through Get A Job.ai

Pay

Compensation details will be discussed during the screening process and are competitive with senior-level CRA positions in the pharmaceutical industry.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applicants from all backgrounds and provide equal employment opportunities regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic.