Clinical Research Associate – Immunology

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

📋 Description

• Ensure performance and compliance for designated protocols and sites.

• Guarantee that the study conduct adheres to ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting obligations.

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

• Develop and expand the clinical research territory by identifying and nurturing new sites.

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

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

• Execute clinical study site management and monitoring in line with applicable requirements.

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

• Coordinate tasks with sponsor roles to ensure site readiness.

• Engage in site selection and validation activities.

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

• Carry out validation, initiation, monitoring, and close-out visits.

• Prepare clear, comprehensive, and accurate reports for visits and non-visit contacts.

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

• Communicate with investigators and site staff concerning protocol adherence, recruitment, retention, deviations, documentation, audits, inspections, and site performance.

• Identify, assess, 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 other systems.

• Contribute to the CRA team’s knowledge as a subject matter expert, 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

• Associate's degree, certificate, or equivalent in a scientific or healthcare discipline, along with at least 5 years of relevant healthcare experience, 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.

• Experience in Immunology is preferred.

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

• A current driver's license is required.

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

• Understanding of clinical research, clinical trial phases, GCP/ICH, and country-specific clinical research laws and guidelines.

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

• Knowledge of Good Documentation Practices.

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

• High-level monitoring skills with the ability to exercise independent professional judgment.

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

• Capability to understand and analyze data/metrics.

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

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

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

• Capacity to operate effectively in a matrix multicultural environment.

• Strong commitment to customer focus and quality/compliance.

• Knowledge of Adverse Event Reporting Systems, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Cultural Awareness, Customer Centricity, Document Management, Good Clinical Data Management Practices (GCDMP), Good Clinical Practice (GCP), Matrix Management, On-Site Management, Pharmaceutics, Protocol Adherence, Protocol Review, Regulatory Affairs Management, Regulatory Compliance, Regulatory Inspections, Relationship Building, Remote Monitoring, Site Management, and Study Design.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, and vision healthcare.

• Additional insurance benefits for employees and their families.

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

• Paid holidays.

• Vacation days.

• Compassionate leave.

• Sick leave.

• Remote work arrangement.

• No relocation required.