Clinical Research Associate – Vaccine, Infectious Disease

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

📋 Description

• Ensure the performance and compliance of assigned protocols and sites within the country.

• Make certain that study conduct adheres to ICH/GCP, national regulations, company policies, quality standards, and adverse event reporting requirements.

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

• Expand and develop the clinical research territory by identifying and cultivating new sites.

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

• Execute clinical study site management and monitoring tasks.

• Acquire a comprehensive understanding of study protocols and associated procedures.

• Coordinate activities with sponsor roles to ensure site readiness.

• Engage in site selection and validation processes.

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

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

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

• Communicate 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, IRBs/IECs, and regulatory authorities.

• Maintain information and documentation in CTMS, eTMF, and additional systems.

• Contribute as a subject matter expert, mentor/buddy, and sharer of best practices.

• Support or lead audit and inspection processes.

• Conduct co-monitoring visits when appropriate.

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

⛳️ Requirements

• Associate’s degree, certificate, or equivalent in a scientific/healthcare field plus 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.

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

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

• Strong grasp of global and country/regional clinical research guidelines.

• Practical knowledge of Good Documentation Practices.

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

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

• Proficient IT skills, including MS Office and clinical IT applications.

• Ability to comprehend and analyze data/metrics.

• Skilled in managing complex issues and conducting root cause analysis.

• Capacity to implement preventative and corrective actions.

• Effective time management, organizational, interpersonal, conflict management, problem-solving, and prioritization abilities.

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

• Capability to function efficiently in a matrix multicultural environment.

• Dedication to customer focus and quality/compliance.

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

• Current driver’s license is preferred.

• No visa sponsorship available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate and sick days.

• Remote work arrangement.

• No relocation required.