Clinical Research Associate – Immunology

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

📋 Description

• Ensure effective performance and adherence to protocols and sites within a designated country.

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

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

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

• Actively participate in internal meetings and workstreams, contributing as a subject matter expert on monitoring processes and systems.

• Build robust relationships with sites and ensure continuity throughout all phases of trials.

• Conduct clinical study site management and monitoring activities in accordance with applicable standards, regulations, protocols, and monitoring plans.

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

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

• Engage in site selection and validation processes.

• Carry out remote and on-site monitoring and oversight activities.

• Conduct validation, initiation, monitoring, and close-out visits; prepare timely reports for both visit and non-visit contacts.

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

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

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

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

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

• Contribute to the CRA team’s knowledge as a process subject matter expert, mentor, and by sharing best practices.

• 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

• An Associate's degree, certificate, or equivalent in a scientific or healthcare discipline along with a minimum of 5 years of relevant experience in the healthcare sector, 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.

• Preferred experience in Immunology.

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

• A current driver's license is required.

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

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

• Good comprehension of Global, Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven site management skills, including oversight of site performance and patient recruitment.

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

• Proficient IT skills, including MS Office and clinical IT applications across computer, tablet, and mobile devices.

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

• Capability to manage complex issues and adopt a solution-oriented approach.

• Experience in root cause analysis and implementing preventative/corrective actions.

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

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

• Skill in setting priorities and managing multiple tasks simultaneously.

• Effectiveness in a matrix multicultural environment while maintaining culturally sensitive working relationships.

• Customer-focused with a strong quality and compliance mindset.

• A positive, growth-oriented mindset and self-driven attitude.

• Professional demeanor and communication aligned with organizational policies and practices.

• Open to US and Puerto Rico residents only.

• Visa sponsorship is not available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical healthcare benefits for employee and family.

• Dental healthcare benefits for employee and family.

• Vision healthcare benefits for employee and family.

• Additional insurance benefits for employee and family.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate leave.

• Sick days.

• Remote work arrangement.

• No relocation assistance offered.