Clinical Research Associate – Neurology

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

📋 Description

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

• Confirm that the study execution aligns with ICH/GCP, local regulations, company policies and procedures, quality standards, and adverse-event reporting obligations.

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

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

• Engage in internal meetings and workstreams as a Subject Matter Expert in the monitoring process.

• Build and maintain strong relationships with sites to ensure continuity across all trial phases.

• Conduct clinical study site management and monitoring in accordance with ICH-GCP, Sponsor SOPs, local laws and regulations, protocols, site monitoring plans, and associated documents.

• Coordinate tasks with sponsor roles to ensure readiness of the site.

• Provide insights on site selection and validation processes.

• Execute remote and on-site monitoring and oversight activities.

• Carry out validation, initiation, monitoring, and close-out visits; accurately and promptly document visit and non-visit contact reports.

• Collect, review, and oversee regulatory documentation for study initiation, maintenance, and closure.

• Liaise with investigators and site personnel regarding protocol adherence, recruitment, retention, deviations, documentation, audits/inspections, and site performance.

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

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

• Manage information and documentation within CTMS, eTMF, and other systems.

• Contribute to CRA team knowledge as a process Subject Matter Expert, mentor, and share best practices.

• Support or lead audit and inspection activities.

• Conduct co-monitoring visits as appropriate.

• Identify potential sites and assist in developing their clinical research capabilities in alignment with the country strategy.

⛳️ Requirements

• Associate's degree, certificate, or equivalent in a scientific/healthcare discipline, along 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) plus at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

• Experience in Neurology is preferred.

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

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

• Solid understanding of Global, Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven capabilities in site management, including site performance and patient recruitment oversight.

• Demonstrated high level of monitoring skill with sound independent professional judgment.

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

• Ability to comprehend and analyze data/metrics effectively.

• Capability to manage complex issues and approach problem-solving with a solution-oriented mindset.

• Skills in root cause analysis and implementing preventive/corrective actions.

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

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

• Proficient in working effectively within a matrix multicultural environment while maintaining culturally sensitive working relationships.

• Customer-centric focus coupled with a strong quality/compliance mindset.

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

• A current driver's license is preferred.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, and vision healthcare coverage.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate days off.

• Sick leave.

• Remote work arrangements.