Senior Clinical Research Associate

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

📋 Description

• Execute protocol-level SMM deliverables for designated sites and studies throughout start-up, execution, and close-out phases.

• Conduct monitoring visits, site evaluations, site selection and activation, monitoring close-out activities, and reporting on visits.

• Anticipate and address site issues that may impact timelines.

• Maintain up-to-date clinical trial management systems with site-specific details.

• Provide expertise regarding local regulatory and legal requirements.

• Ensure prompt execution of payments for the assigned sites and studies.

• Guarantee compliance with regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards.

• Stay informed about evolving local regulations, guidelines, and policies.

• Ensure readiness for audits and inspections; provide guidance on pre-audit GCP activities.

• Prepare for and follow up on site audits and inspections and contribute to Corrective and Preventive Action (CAPA) preparation.

• Coach and mentor Clinical Research Associates (CRAs) and support their professional development.

• Act as the country point of contact for Contract Research Organizations (CROs) when designated.

• Participate in or lead both global and local task forces and initiatives.

• Identify training needs and standardize and facilitate training solutions for SMM monitors when assigned.

• Support the onboarding process and compile lessons learned into monitoring training materials and best-practice curricula when designated.

• Serve as a contact for country or district studies when assigned.

• Update Impact/Tesla with country-level planning information and LSR assignments when designated.

• Act as a global representative for studies when appointed.

• Conduct remote data reviews in accordance with IDRP, Monitoring Plan, SOP/WI, timelines, and study objectives when designated.

• Provide continuous feedback regarding investigator and site performance.

• Develop professional and collaborative relationships with colleagues and site monitors.

⛳️ Requirements

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

• A minimum of 3 years of experience in site monitoring.

• Strong analytical and critical thinking abilities.

• Excellent interpersonal and persuasive communication skills.

• Flexibility and adaptability to evolving requirements.

• Resourceful and creative problem-solving skills.

• Proactive and positive team-oriented approach.

• Strong planning and organizational capabilities.

• High level of adaptability in a fast-paced environment with competing projects and deadlines.

• Demonstrated business ethics and integrity.

• Compliance with federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards.

• Knowledge of local regulatory and legal requirements.

• Ability to maintain audit and inspection readiness.

🏝️ Benefits

• Availability for remote work.

• Equal opportunity employer.

• Commitment to operating with integrity, fostering innovation, transforming lives, and serving the community.