Clinical Research Associate; CRA - Cardiovascular; Remote
Elizabeth, Union County, New Jersey, 07201, USA
Listed on 2026-07-13
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Research/Development
Clinical Research, Regulatory Compliance Specialist
Location & Language
Candidate must reside in South Florida (Ft. Lauderdale, Miami, Boca Raton, Key Largo) and be fluent in Spanish and English (verbal and written). The position is open only to U.S. and Puerto Rico residents.
TravelApproximately 65-75% of the working time will be spent traveling domestically and internationally, roughly 2-3 days per week. A valid driver’s license is required.
Responsibilities- Ensure protocol and country regulation compliance for assigned sites.
- Act as primary site contact and manager throughout all phases of clinical research studies.
- Develop and expand the territory for clinical research by identifying and developing new sites.
- Perform site selection, validation, initiation, monitoring, and close‑out visits.
- Maintain accurate, complete, and unbiased data at sites.
- Collect, review, and monitor required regulatory documentation for study start‑up, maintenance, and close‑out.
- Communicate with investigators and site staff on protocol conduct, recruitment, retention, deviations, and overall performance.
- Identify, assess, and resolve site performance, quality, or compliance issues and follow the CRA escalation pathway.
- Collaborate with cross‑functional teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional HQ) and external vendors, IRB/IECs, and regulatory authorities.
- Manage documentation in CTMS, eTMF and other systems per timelines.
- Contribute to CRA team knowledge as a subject matter expert, mentor, and share best practices.
- Support and/or lead audit and inspection activities; perform co‑monitoring visits when appropriate.
- Fluent in Spanish and English; excellent communication skills.
- Strong knowledge of clinical research phases, GCP/ICH regulations, and country guidelines.
- Hands‑on Good Documentation Practices and site management experience.
- Proficient with MS Office and clinical IT applications across devices.
- Data analysis and metric interpretation to inform decision‑making.
- Root cause analysis and implementation of corrective and preventive actions.
- Effective time management, organization, and interpersonal skills.
- Conflict management and problem‑solving abilities.
- High sense of accountability, urgency, and independent prioritization.
- Collaboration in a matrix multicultural environment.
- Professional demeanor consistent with organizational policies.
- Growth mindset and self‑driven motivation.
Associate’s degree or equivalent in a scientific/healthcare discipline with at least 5 years of relevant healthcare experience, including 2 years of direct site management. OR Bachelor’s degree or higher with 2 years of direct site management experience in a biopharma/CRO setting.
Preferred Skills- Adaptability, adverse event reporting systems, clinical research methods.
- Clinical site and study management, clinical trial planning and monitoring.
- Data analysis, reporting, and good clinical data management practice.
- Pharmacovigilance, preventive action, protocol adherence, regulatory compliance.
Salary range for this role is $96,200 – $151,400. Eligible for annual bonus and long‑term incentive if applicable. Comprehensive benefits package includes medical, dental, vision, other insurance coverage, retirement benefits with 401(k), paid holidays, vacation, and compassionate and sick days.
Equal Employment Opportunity StatementAs an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the appropriate government resources.
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