Senior Clinical Research Associate

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

📋 Description

• Ensure effective protocol-level implementation of SMM deliverables for designated sites/studies, encompassing start-up, execution, and close-out phases.

• Perform monitoring visits, site assessments, site selection and activation, monitoring close-out, and prepare visit reports.

• Anticipate and resolve site-related issues that may impact timelines.

• Keep site-specific information up to date in clinical trial management systems.

• Offer expertise in local regulatory and legal requirements.

• Guarantee timely site payments in accordance with clinical study agreements and local regulations.

• Ensure compliance with regulations, GCPs, ICH Guidelines, SOPs, monitoring plans, and quality standards.

• Maintain readiness for audits and inspections; assist with audits, inspections, and the preparation of CAPA.

• Mentor and coach CRAs, contributing to their professional growth.

• Act as the point of contact for CROs in the country when assigned.

• Engage in or lead global/local task forces and initiatives.

• Identify training needs and standardize or facilitate global SMM monitor training when designated.

• Support onboarding processes and integrate lessons learned into monitoring training materials and curricula when assigned.

• Update country-level planning data in Impact/Tesla when designated.

• Collaborate with stakeholders as a global study representative when assigned.

• Conduct remote data reviews in accordance with study plans, SOPs, timelines, and objectives when designated.

• Provide ongoing feedback on site performance.

• Foster professional and collaborative relationships with peers and site monitors.

⛳️ Requirements

• Bachelor's degree or equivalent in a health-related field (e.g., Medical, Scientific, Nursing, Pharmacy) is preferred.

• At least 3 years of experience in site monitoring.

• Strong analytical and critical thinking abilities.

• Exceptional interpersonal skills with clear and persuasive communication.

• Ability to be flexible and adapt to changing requirements.

• Resourceful and creative in problem-solving.

• Proactive and positive approach as a team player.

• Strong planning and organizational capabilities.

• High degree of flexibility in a fast-paced environment with competing projects and deadlines.

• Strong adherence to business ethics and integrity.

• Familiarity with federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and monitoring plans.

🏝️ Benefits

• Employees have the option to work remotely.

• Commitment to being an equal opportunity employer.

• Dedicated to employing veterans and individuals with disabilities.