Clinical Research Associate II – Neurology

Jobtailor; Deutschland; Remote; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

AbbVie seeks a Clinical Research Associate to monitor and manage clinical sites across trials. You will train site staff, ensure protocol adherence, and coordinate with investigators to align on patient treatment principles.

Travel up to 75% of the time, with a focus on risk-based monitoring, regulatory compliance, and timely data submission. Collaboration with Central Monitoring and global teams is essential.

Qualifikationen

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience.
• At least 6 months of clinical research monitoring experience involving investigational drug or device trials.
• Knowledge of ICH/GCP Guidelines and local regulatory requirements.
• Strong cross-functional collaboration and organizational skills.

Aufgaben

• Advance AbbVie's clinical research pipeline and support innovative medicines and solutions.
• Serve as the primary point of contact for investigative sites.
• Provide contextual information on clinical trials and connect stakeholders with sites.
• Align, train, and motivate site staff and investigators on trial goals and patient treatment principles.
• Conduct site evaluation, training, monitoring, and site closure monitoring.
• Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards.

Kenntnisse

Cross-functional collaboration

Planning & organization

Dynamic environment handling

Technology & tools utilization

Interpersonal/written/verbal skills

Ausbildung

Health-related tertiary qualification

Tools

CRM Tools

Monitoring Tools

Jobbeschreibung

• Advance AbbVie's clinical research pipeline and support innovative medicines and solutions
• Serve as the primary point of contact for investigative sites
• Provide contextual information on clinical trials and connect stakeholders with investigative sites
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Conduct site evaluation, site training, routine monitoring, and site closure monitoring
• Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
• Develop and customize site engagement strategies for assigned studies
• Gather site insights and use CRM tools to report and track progress and measure impact
• Connect study protocols, scientific principles, and clinical trial requirements to daily trial execution
• Evaluate recruitment and retention techniques based on the patient disease journey
• Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global or local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team
• Monitor clinical-site activities for study-performance and patient-safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate, and recommend investigators and clinical sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness
• Manage investigator payments according to executed contract obligations

Requirements

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred
• Minimum of 1 year of clinically related experience
• At least 6 months of clinical research monitoring experience involving investigational drug or device trials
• Familiarity with risk-based monitoring, onsite and offsite monitoring
• Knowledge of therapeutic area indications preferred
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Strong cross-functional collaboration skills
• Strong planning and organizational skills
• Ability to work effectively in a dynamic environment with competing projects and deadlines
• Advanced ability to leverage technology, tools, and resources
• Strong interpersonal, written, verbal, active listening, and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships
• Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues
• Integrity in accordance with AbbVie code of business conduct and leadership values
• Self‑motivated and focused on timely, quality outcomes
• Willingness to travel 75% of the time

Core Competencies

Demonstrates expertise in clinical research monitoring, compliance with ICH/GCP Guidelines, and effective site engagement strategies. Possesses strong interpersonal and organizational skills to manage investigator relationships and ensure quality outcomes in a dynamic environment.

Highest-signal resume keywords

• Clinical Research Monitoring
• ICH/GCP Guidelines ComplianceSite Engagement Strategies
• Cross-Functional Collaboration
• Risk-Based Monitoring

ATS Optimization Keywords

Hard Skills

• Clinical Research
• Site Evaluation
• Patient Treatment Principles
• Regulatory Compliance
• Data Submission
• Safety-Event Reporting
• Monitoring Plans
• Recruitment Techniques
• Therapeutic Area Knowledge
• Risk Assessment

Soft Skills

• Interpersonal Skills
• Organizational Skills
• Critical Thinking
• Active Listening
• Presentation Skills

Industry Keywords

• Clinical Trials
• Investigational Drug Trials
• Health-Related Disciplines
• Audit Readiness
• Patient Safety

Tools & Technologies

• CRM Tools
• Monitoring Tools
• Technology Resources