Clinical Research Associate

1 settimana fa

Lombardia, Italia Buscojobs A tempo pieno

Work Schedule Standard (Mon-Fri)

Environmental Conditions

Office

At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

This is a great opportunity for CRA's currently working within the life science sector for pharmaceutical companies, biotech companies or CRO's to work with a world-leading CRO across multiple sponsors, various protocols and therapy areas.

These roles can be performed remotely for CRA's based close to our clinical 'hubs': Milan, Bologna, Florence, Rome and Naples. Travel requirement will be national across Italy.

Essential Functions:

  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  • Assess investigational product through physical inventory and records review.
  • Documents observations in reports and letters according to timelines using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  • Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
  • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
  • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required.

Education and Experience:

  • University degree in a science related field
  • CRA Qualified as per the Ministerial Decree dated 15/11/2011 and at least 1 year of independent monitoring experience in clinical development phases II-IV
  • Understanding of ICH-GCP, EU and FDA requirements
  • Fluency in English and in Italian
  • Valid Driver's License

Knowledge, Skills and Abilities:

  • Proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
  • Ability to manage Risk Based Monitoring concepts and processes
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
  • Good organizational and time management skills
  • Effective interpersonal skills
  • Attention to detail
  • Ability to remain flexible and adaptable in a wide range of scenarios
  • Ability to work in a team or independently as require
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you

Original job Clinical Research Associate - FSP posted on GrabJobs . To flag any issues with this job please use the Report Job button on GrabJobs.

#J-18808-Ljbffr

  • Clinical Research Associate Ii

    5 giorni fa

    Lombardia, Italia Buscojobs A tempo pieno

    6 giorni fa PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Clinical Research Associate at PSI Italy, you...

  • Sr. Clinical Research Associate

    1 settimana fa

    Lombardia, Italia Buscojobs A tempo pieno

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently recruiting for an experienced Senior Clinical Research Associate in Italy to...

  • Clinical Research Associate

    2 settimane fa

    Lombardia, Italia Buscojobs A tempo pieno

    Descrizione azienda Siamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13 / I / 5640), su tutto il territorio nazionale. Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è...

  • Associate Clinical Science Development Director

    16 ore fa

    Lombardia, Italia Buscojobs A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Position Overview The Associate Director, Clinical Development Science provides clinical development expertise into a multi-disciplinary team engaged in advising clients in early through late-stage development of medical products. Input will be provided into the design and conduct of...

  • Senior Clinical Research Associate

    1 settimana fa

    Lombardia, Italia Buscojobs A tempo pieno

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently recruiting for an experienced Sr. CRA - Italy and Hungary: This particular CRA...

  • Clinical Research Associate Ii

    1 settimana fa

    Lombardia, Italia Buscojobs A tempo pieno

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Clinical Research Associate II (CRAII) to join our A-team (hybrid* / remote). As a CRAII at Allucent, you will independently...

  • Clinical Research Associate

    2 settimane fa

    Santa Maria (San Siro) Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with...

  • Clinical Research Associate

    5 giorni fa

    Lombardia, Italia Buscojobs A tempo pieno

    Job Description National Travel Required Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study. Identifies the investigators and verifies that the investigator has adequate qualifications,...

  • Post-Doctoral & Research Associate Positions

    1 settimana fa

    Lombardia, Italia Buscojobs A tempo pieno

    IRCCS San Raffaele Scientific Institute in Milan, Italy, is looking for a Postdoctoral Researcher and Research Associate to join the Gianfranco Soldera Prostate Cancer Lab at the Urological Research Institute, led by Professor Alberto Briganti. Our team is dedicated to advancing the understanding of prostate cancer by studying its progression, identifying...

  • Clinical Trial Coordinator

    1 settimana fa

    Lombardia, Italia Buscojobs A tempo pieno

    Clinical Trial Coordinator - Segrate, Milan At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career...

  • Associate Counsel, Legal Contracts

    2 mesi fa

    Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Other Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to...

  • Csr Clinical Study Administrator

    2 giorni fa

    Lombardia, Italia Buscojobs A tempo pieno

    Clinical Study Administrator, Country Operations Management This is what you will do: The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives...

  • Clinical Project Manager

    3 settimane fa

    Santa Maria (San Siro) Lombardia, Italia Ora A tempo pieno

    POSITION TITLE: Clinical Project Manager DEPARTMENT: Ora Europe LOCATION: Remote, UK, Spain, Italy or Poland Ora Values the Daily Practice of ... Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and...

  • Associate Counsel, Legal Contracts

    3 settimane fa

    Santa Maria (San Siro) Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Other Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to...

  • Field Clinical Specialist, Vascular Peripheral Interventions

    2 settimane fa

    Lombardia, Italia Buscojobs A tempo pieno

    Location : the position is open on a remote working schedule, based preferably in the Northern Italy area. About the Role : Join our dynamic Italian Vascular Peripheral Interventions team as a Field Clinical Specialist (FCS). In this role, you will provide crucial clinical, technical, and educational support to our clients across various levels. Your...

  • Associate or Full Professor

    3 settimane fa

    Villanova (Bernareggio) Lombardia, Italia VILLANOVA UNIVERSITY A tempo pieno

    Associate or Full Professor – Tenure Eligible FCN is hiring for two positions at the full or associate professor rank. Full professor is preferred. Applicants must be tenure-eligible. For full or associate professor rank, candidates must meet FCN and University criteria for appointment at the full or associate professor rank. Applications must include a...

  • Assistant/Associate Director, Global Fellowships

    1 settimana fa

    Villanova (Bernareggio) Lombardia, Italia VILLANOVA UNIVERSITY A tempo pieno

    Assistant/Associate Director, Global Fellowships To view the position details and/or apply to a position, click on the View Details link below the Job Title. If you have questions about the application process, please refer to the Applicant FAQ's . Posting Details Posting Number: 20244215S Position Title: Assistant/Associate Director, Global Fellowships...

  • Associate General Counsel

    3 settimane fa

    Villanova (Bernareggio) Lombardia, Italia VILLANOVA UNIVERSITY A tempo pieno

    Associate General Counsel (Data Privacy/Security & Transactional) To view the position details and/or apply to a position, click on the View Details link below the Job Title. If you have questions about the application process, please refer to the Applicant FAQ's . Posting Details Posting Number: 20244159S Position Title: Associate General Counsel (Data...

  • Sr Manager Clinical Supplies

    2 settimane fa

    Santa Maria (San Siro) Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the...

  • Local Study Manager

    2 settimane fa

    Lombardia, Italia Buscojobs A tempo pieno

    The Local Study Manager is responsible for the setup and progress of a clinical trial/observational study/special program in his/her own country or in the assigned countries in the South Europe & Italy Cluster. Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their...