Clinical Research Associate

Pharmaceutical Research Associates, Inc; Napoli; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

Une entreprise de recherche clinique de premier plan recherche un Associé de recherche clinique pour rejoindre leur équipe à Naples. Vous serez responsable de la gestion et de la supervision des essais cliniques, garantissant que toutes les procédures sont respectées et que les documents sont précis. Ce rôle exige une expérience en recherche clinique, ainsi que des compétences solides en communication et en gestion des sites. L'entreprise offre un environnement de travail inclusif avec des opportunités de carrière et des avantages compétitifs.

Servizi

Assurance santé

Plan de retraite

Programme d'assistance aux employés

Congés annuels variés

Assurance vie

Avantages optionnels flexibles

Competenze

• Vous devez avoir un diplôme BA / BS minimum; préférence pour un degré en santé ou science.
• Une expérience indépendante de surveillance est obligatoire.
• Une bonne maîtrise de l'anglais et de la langue du pays est nécessaire.

Mansioni

• Participe aux évaluations des sites et à la gestion des essais cliniques.
• Agit comme contact principal pour les sites assignés.
• S'assure que le personnel du site est formé et que les documents sont à jour.

Conoscenze

Connaissance en ICH-GCP

Compétences en communication

Compétences informatiques

Formazione

BA / BS degree (préférablement en science ou santé)

Descrizione del lavoro

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

The role :

• Participates in site feasibility and / or pre-trial site assessment visits, providing recommendation from local area about site / investigator selection in collaboration with the trial team
• Acts as primary local company contact for assigned sites for specific trials.
• Attends / participates in investigator meetings as needed.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site / study close-out according to internal SOPs / WIs / IFUs and policies.
• Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• Ensures that all AEs / SAEs / PQCs are reported within the required reporting timelines and documented as appropriate. For AEs / SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF / IF, Trial Master Source and Sharepoints).
• May be assigned as a coach and mentor to a less experienced site manager.
• May contribute to process improvement and training.
• Leads and / or participates in special initiatives as assigned.
• May assume additional responsibilities or special initiatives such as Champion or Therapeutic Area Expert.

Qualifications

To be successful in the role, you will have :

• A minimum of a BA / BS degree is required. A degree in a health or science related field is preferred.
• Independent monitoring experience is mandatory.
• Must have experience in Clinical Research or equivalent qualification
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
• Proficient in speaking and writing the country language and English.
• Good written and oral communication skills.

What ICON can offer you :

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include :

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON : ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

J-18808-Ljbffr

Clinical Research Associate • napoli, Italia