Clinical Research Associate – Cardiovascular

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

📋 Description

• Ensure the performance and adherence to compliance for assigned protocols and sites within the country.

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

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

• Enhance and expand the clinical research territory by identifying and developing new sites.

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

• Foster site relationships and ensure continuity across all trial phases.

• Execute clinical study site management and monitoring tasks.

• Coordinate and manage tasks with sponsor roles to reach Site Ready status.

• Take part in site selection and validation processes.

• Conduct both remote and on-site monitoring and oversight activities.

• Carry out validation, initiation, monitoring, and close-out visits while documenting visit and non-visit contact reports.

• Gather, review, and monitor regulatory documentation for study initiation, maintenance, and closure.

• Communicate with Investigators and site personnel regarding protocol execution, recruitment, retention, deviations, documentation, audits, and site performance.

• Identify, evaluate, address, 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 subject matter expert, mentor, and by sharing best practices.

• Support and/or lead audit and inspection activities.

• Conduct co-monitoring visits.

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

⛳️ Requirements

• Associate's degree, certificate, or equivalent in a scientific/healthcare discipline combined with at least 5 years of relevant experience in the healthcare field, including a minimum of 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.

• Proficient in local languages and English (both verbal and written).

• Solid understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH, and national clinical research laws and guidelines.

• Good grasp of Global and Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Demonstrated skills in site management, which includes overseeing site performance and patient recruitment.

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

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

• Capability to understand and analyze data/metrics.

• Ability to conduct root cause analysis and implement preventive and corrective actions.

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

• Capable of working independently across multiple protocols, sites, and therapy areas.

• Skillful in setting priorities and managing multiple tasks simultaneously.

• Ability to work effectively in a matrix multicultural environment.

• Commitment to customer focus and adherence to high quality/compliance standards.

• Current driver's license preferred.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical healthcare.

• Dental healthcare.

• Vision healthcare.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation.

• Compassionate days.

• Sick days.

• Remote work arrangement.