Clinical Research Associate II

3 settimane fa

Milano, Lombardia, Italia Allucent A tempo pieno
Key Responsibilities

The ideal candidate will have at least 2 years of experience in clinical trials and a strong therapeutic background. As a Clinical Research Associate II, you will be responsible for independently controlling and monitoring investigation sites, detecting issues proactively, and providing solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.

Key Tasks:
  1. Governs quality standards for trial monitoring activities.
  2. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements.
  3. Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  4. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
  5. Collects and reviews regulatory documents as required.
  6. Prepares site visit reports and telephone contact reports.
  7. Maintains and updates CTMS in compliance with SOPs and study-specific directives.
  8. Acts as Document Owner for collected documents.
  9. May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management.
  10. Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
  11. Acts as the main line of communication between the project team and the site staff.
  12. Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight.
  13. Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution.
  14. Ensures the continuous maintenance of the Trial Master File and Investigator Site File.
  15. Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.
  16. Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts.
  17. Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings.
  18. May translate, coordinate translations or review completed translations of the essential documents as required.
  19. May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department.
  20. Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation.
  21. Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
  22. May process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income.
  23. Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
  24. Provides secondary in-house review of CRFs (if required).
  25. Support site staff in preparation for study related site audits and inspections.
  26. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.
  27. May be assigned other tasks / activities / responsibilities related to the study execution in the country.
  28. May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality.
  29. Must work both independently and in a team environment.

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Lombardia, Italia Meet Recruitment Inc. A tempo pieno

    Clinical Research Associate II Role OverviewClinical Research Associate II/Senior (CRA II/Senior CRA): Meet Recruitment Inc. is seeking a skilled Clinical Research Associate II to join our pharmaceutical and healthcare team. This is an excellent opportunity to work for a top CRO with a global presence, providing a wide range of high-profile strategic...

  • Clinical Research Associate II

    4 settimane fa

    Milano, Lombardia, Italia Allucent A tempo pieno

    Job Title: Clinical Research Associate IIWe are seeking a highly skilled Clinical Research Associate II to join our team at Allucent. As a Clinical Research Associate II, you will play a critical role in the success of our clinical trials by ensuring that all study activities are conducted in accordance with Good Clinical Practice (GCP) and applicable...

  • Clinical Research Associate II

    1 mese fa

    Milano, Lombardia, Italia Ora, Inc. A tempo pieno

    About Ora, Inc.Ora, Inc. is a leading company in ophthalmic product development, with over 45 years of experience. We are dedicated to fostering career growth and provide training, development programs, and internal promotion opportunities for qualified individuals.Job SummaryWe are seeking a highly skilled Clinical Research Associate II to join our team....

  • Clinical Research Associate II Position

    1 mese fa

    Milano, Lombardia, Italia Meet Recruitment Inc. A tempo pieno

    Clinical Research Associate II RoleMeet Recruitment Inc. is seeking a skilled Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for working with our industry-leading CRO to expand its CRA division. This is a great opportunity to work with a global presence, providing ample opportunity for career...

  • Clinical Research Associate II Position

    4 settimane fa

    Milano, Lombardia, Italia Psi Cro Ag A tempo pieno

    Job Title: Clinical Research Associate IIJob Summary:Clinical Research Associates play a vital role in ensuring the quality and integrity of clinical trials. As a Clinical Research Associate II at PSI, you will be responsible for conducting onsite monitoring visits, reviewing case report forms, and communicating with site staff. If you have a strong...

  • Clinical Research Associate II

    4 settimane fa

    Milano, Lombardia, Italia PSI CRO A tempo pieno

    Job Title: Clinical Research Associate IIJob Summary:We are seeking a highly skilled Clinical Research Associate II to join our team at PSI CRO. As a Clinical Research Associate, you will be responsible for conducting and reporting onsite monitoring visits, participating in study startup, and performing CRF review, source document verification, and query...

  • Clinical Research Associate II

    1 mese fa

    Milano, Lombardia, Italia Psi Cro Ag A tempo pieno

    Clinical Research Associate II Opportunity at PSI ItalyPSI Italy is a leading Contract Research Organization with over 28 years of experience in the industry. We offer a perfect balance between stability and innovation to both clients and employees. Our focus is on delivering quality and on-time services across various therapeutic indications.As a Clinical...

  • Clinical Research Associate II

    2 settimane fa

    Milano, Lombardia, Italia Pharmiweb A tempo pieno

    About the Role:The Study Start Up Associate II will play a crucial part in ensuring that physicians at our research sites are prepared to initiate clinical trials of investigational new pharmaceutical and biological products. Key responsibilities include reviewing and negotiating clinical site investigator contracts and budgets, staying connected with...

  • Clinical Research Associate II

    1 mese fa

    Milano, Lombardia, Italia Psi Cro A tempo pieno

    At PSI, we are seeking a Clinical Research Associate II to join our team in Italy. As a Clinical Research Associate, you will be responsible for conducting and reporting onsite monitoring visits, as well as performing CRF review, source document verification, and query resolution. You will also be involved in study startup, site communication and management,...

  • Clinical Research Associate II

    2 settimane fa

    Milano, Lombardia, Italia PSI CRO A tempo pieno

    Role OverviewWe are seeking a highly skilled Clinical Research Associate II to join our team at PSI CRO. As a Clinical Research Associate II, you will be responsible for conducting onsite monitoring visits, ensuring the highest quality standards in clinical research.Job DescriptionThis role offers an exciting opportunity to work on clinical studies in...

  • Clinical Research Associate II Role

    3 settimane fa

    Milano, Lombardia, Italia PSI A tempo pieno

    Job Title: Clinical Research Associate IIAt PSI, we are seeking an experienced Clinical Research Associate II to join our team in Italy. As a key member of our team, you will be responsible for conducting onsite monitoring visits, reporting on study progress, and ensuring the highest quality standards in clinical research.Responsibilities:Conduct onsite...

  • Clinical Research Associate II

    3 settimane fa

    Milano, Lombardia, Italia Pharmiweb A tempo pieno

    Job Title: Clinical Research Associate IIAs a leading global contract research organization, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in over 90 countries, Fortrea is transforming drug...

  • Clinical Research Associate II

    1 settimana fa

    Milano, Lombardia, Italia Allucent A tempo pieno

    Job OverviewAllucent is a leading biopharmaceutical company that specializes in helping small-medium companies navigate the complex world of clinical trials. We are seeking an experienced Clinical Research Associate II to join our team and play a crucial role in ensuring the success of our clinical studies.

  • Clinical Research Associate II Position

    3 settimane fa

    Milano, Lombardia, Italia Allucent A tempo pieno

    Clinical Research Associate II Role OverviewAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials. We are seeking a Clinical Research Associate II to join our team and contribute to the success of our clients. This position will be responsible for independently controlling and...

  • Clinical Research Associate II

    3 settimane fa

    Milano, Lombardia, Italia Allucent A tempo pieno

    About the RoleWe are seeking a highly skilled Clinical Research Associate II to join our team at Allucent. As a key member of our Clinical Operations department, you will be responsible for ensuring the high-quality execution of clinical trials.Key ResponsibilitiesSite Monitoring: Independently control and monitor investigation sites, proactively detecting...

  • Clinical Research Associate II/Sr CRA

    1 mese fa

    Milano, Lombardia, Italia Pharmiweb A tempo pieno

    Job Title: Clinical Research Associate II/Sr CRAJob Summary:We are seeking a highly skilled Clinical Research Associate II/Sr CRA to join our team at Pharmiweb. As a Clinical Research Associate II/Sr CRA, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure...

  • Clinical Research Associate II Position

    2 settimane fa

    Milano, Lombardia, Italia Allucent A tempo pieno

    Job DescriptionAt 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.Job SummaryWe are seeking a skilled Clinical Research Associate II to join our team. The ideal candidate will have a strong background...

  • Senior Clinical Research Associate

    14 ore fa

    Milano, Lombardia, Italia Psi CRO Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateAt PSI CRO Ag, we offer a perfect balance between stability and innovation to both clients and employees.As a clinical research associate at our organization, you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications.We maintain the highest...

  • Clinical Research Associate II

    1 mese fa

    Milano, Lombardia, Italia Tn Italy A tempo pieno

    Clinical Research Associate IIAt Tn Italy, 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 seeking a Clinical Research Associate II to join our team. As a CRA II at Tn Italy, you will independently...

  • Clinical Research Associate II Transformation Specialist

    2 settimane fa

    Milano, Lombardia, Italia Psi CRO Ag A tempo pieno

    About Us:PSI CRO Ag is a leading Contract Research Organization with over 28 years of experience in the industry, offering a perfect balance between stability and innovation to clients and employees alike.We focus on delivering high-quality, timely services across various therapeutic indications, ensuring our clients receive exceptional results.Your Role:As...