Clinical Research Associate, Cardiovascular – Bilingual English/Spanish

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Ensure performance and compliance for designated protocols and sites within the country.

• Guarantee that study conduct aligns with ICH/GCP, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

• Serve as the primary contact and site manager throughout all phases of clinical research studies.

• Develop and enhance the clinical research territory by identifying and cultivating new sites.

• Engage in internal meetings and workstreams as a subject matter expert on monitoring processes and systems.

• Build strong relationships with sites and ensure continuity throughout trial phases.

• Execute clinical study site management and monitoring in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, the protocol, site monitoring plan, and associated documents.

• Attain a comprehensive understanding of study protocols and related procedures.

• Coordinate and manage tasks in collaboration with sponsor roles to ensure site readiness.

• Take part in site selection and validation activities.

• Conduct remote and on-site monitoring and oversight to ensure complete, accurate, and unbiased site data while protecting subjects' rights, safety, and well-being.

• Carry out validation, initiation, monitoring, and close-out visits; prepare timely, clear, comprehensive, and accurate visit and non-visit contact reports.

• Gather, review, and oversee regulatory documentation for study start-up, maintenance, and close-out.

• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance.

• Identify, evaluate, resolve, and escalate site performance, quality, and compliance issues.

• Collaborate with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, IRBs/IECs, and regulatory authorities.

• Manage and maintain information and documentation in CTMS, eTMF, and other systems.

• Contribute to CRA team knowledge as a process SME, mentor, and best-practice sharer.

• Support or lead audit and inspection activities.

• Conduct co-monitoring visits when appropriate.

• Identify potential new sites and assist in developing their clinical research capabilities.

⛳️ Requirements

• Fluent Spanish speaking skills are essential.

• Proficient in local languages and English, both verbal and written.

• An Associate's degree, certificate, or equivalent in a scientific/healthcare discipline, along with a minimum of 5 years of relevant healthcare experience, including at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO; or a Bachelor's degree or higher with at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

• Strong understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and local clinical research laws and guidelines.

• Familiarity with global and country/regional clinical research guidelines.

• Practical knowledge of Good Documentation Practices.

• Demonstrated site management skills, including site performance and patient recruitment.

• Proven high-level monitoring skills with independent professional judgment.

• Proficient IT skills, including MS Office and clinical IT applications on computers, tablets, and mobile devices.

• Ability to understand and analyze data/metrics and respond appropriately.

• Capable of managing complex issues and working in a solution-oriented manner.

• Experience with root cause analysis and implementing preventive/corrective actions.

• Strong time management, organizational, interpersonal, conflict management, and problem-solving skills.

• Ability to work independently across multiple protocols, sites, and therapeutic areas.

• Capacity to prioritize and manage multiple tasks in a dynamic environment.

• Ability to work effectively in a multicultural matrix environment.

• Customer focus and a strong quality/compliance mindset.

• Positive growth mindset with a self-driven work ethic.

• A current driver's license is preferred.

• Willingness to travel domestically and internationally approximately 65%-75% of working time; expected travel is approximately 2-3 days per week.

• Residency in the US or Puerto Rico is required.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, and vision healthcare.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate days.

• Sick days.

• Remote work arrangement.

• No relocation required.