Clinical Research Associate Ii Immunology (Field Role, Nationwide Coverage)

Abbvie; Lazio; In loco; EUR 55.000 - 75.000; Tempo pieno

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Descrizione del lavoro

AbbVie cerca un Career CRA per guidare il monitoraggio di studi clinici presso siti italiani. La funzione garantisce la conformità ai protocolli, la qualità dei dati e una gestione efficace della sicurezza dei pazienti.

La risorsa comunicherà con team interni, investigator e staff di sito, fornendo formazione e supporto continuo per migliorare le prestazioni degli studi e l’esperienza del sito.

Competenze

• Laurea o titolo equivalente in campo sanitario/scientifico.
• Esperienza minima di 1 anno in monitoraggio clinico o studi rapidi.
• Conoscenza avanzata di normative GCP/ICH e delle pratiche regolatorie locali.

Mansioni

• Agisce come punto di contatto principale per i siti investigativi per i trial clinici.
• Allena e motiva lo staff del sito sui protocolli e sugli obiettivi dello studio.
• Conduce valutazioni dei siti, training e monitoraggio sul campo e off-site nel rispetto di GMP/ICH.

Conoscenze

Team collaboration

Regulatory/ICH-GCP knowledge

Site monitoring

Risk management

Communication

Formazione

Laurea triennale o equivalente (sanità/biomed/ciências)**

Descrizione del lavoro

Descrizione dell’offerta di lavoro

Questa posizione è in AbbVie

Il processo di selezione sarà interamente gestito AbbVie.

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Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

• Considered as the primary Sponsor point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholders to the investigative sites and strengthens AbbVieâs positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance with the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
• Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patientâs disease journey.
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
• May participate in global/local task forces and initiatives. Responsible for activities assigned by manager.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures audit and regulatory inspection readiness at always assigned clinical site.
• Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

• Bachelorâs degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
• Valid driverâs license
• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‑based monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Self-motivated individuals focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

Your total reward package at AbbVie will be made up of multiple components, including compensation, well-being and benefits. In this role, you will receive a number of benefits including life assurance, medical plan, flexible benefits, etc. You will also be entitled to receive a company car. Full details of our comprehensive package will be shared during the recruitment process. The national collective bargaining agreement applicable to this position is B011 â CCNL Chemical-Pharmaceuticals Industry. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html