Lavori attuali relativi a Clinical Research Associate II - Milano, Lombardia - Allucent


  • 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...


  • Milano, Lombardia, Italia Allucent A tempo pieno

    Job Title: Clinical Research Associate IIAbout the Role:We 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-related activities are conducted in accordance with Good Clinical Practice...


  • Milano, Lombardia, Italia Allucent A tempo pieno

    Job Title: Clinical Research Associate IIAbout the Role:We 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),...


  • 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...


  • 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....


  • Milano, Lombardia, Italia Psi CRO Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateJob Summary:We are seeking a highly skilled Clinical Research Associate II to join our team at PSI CRO Ag. As a Clinical Research Associate, you will be responsible for conducting and reporting onsite monitoring visits, participating in study startup, and ensuring the highest quality...


  • Milano, Lombardia, Italia Psi Cro Ag A tempo pieno

    Join Our Team as a Clinical Research Associate IIWe are seeking a highly motivated and experienced Clinical Research Associate II to join our team at PSI Italy. As a key member of our clinical research team, you will be responsible for conducting and reporting onsite monitoring visits, performing CRF review, and ensuring the highest quality standards in the...


  • 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...


  • Milano, Lombardia, Italia Psi Cro Ag A tempo pieno

    Join Our Team as a Clinical Research Associate IIWe are seeking a highly motivated and experienced Clinical Research Associate II to join our team at PSI Italy. As a key member of our clinical research team, you will be responsible for conducting and reporting onsite monitoring visits, ensuring the highest quality standards in the industry.Key...


  • 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...


  • Milano, Lombardia, Italia Tn Italy A tempo pieno

    Job Title: Clinical Research Associate IIAt Tn Italy, we are seeking a highly skilled Clinical Research Associate II to join our team. As a key member of our clinical research team, you will be responsible for conducting clinical trials and ensuring the highest level of quality and integrity in our research.Key Responsibilities:Conduct clinical trials in...


  • Milano, Lombardia, Italia Tn Italy 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 CRA II, you will play a critical role in ensuring the successful execution of clinical trials.Key Responsibilities:Monitor investigation sites to ensure compliance with study protocols and regulatory requirements.Perform...


  • Milano, Lombardia, Italia PSI CRO A tempo pieno

    Job Title: Clinical Research Associate IIPSI CRO is seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a Clinical Research Associate, you will be responsible for conducting and reporting onsite monitoring visits, as well as being involved in study startup and site communication and management.Key...


  • Milano, Lombardia, Italia PSI 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 II, you will be responsible for conducting and reporting onsite monitoring visits, participating in study startup, and performing CRF review, source document verification, and query...


  • Milano, Lombardia, Italia Psi CRO Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateJob Summary:We are seeking a highly skilled Clinical Research Associate II to join our team at Psi CRO Ag. As a Clinical Research Associate II, you will be responsible for conducting and reporting onsite monitoring visits, participating in study startup, and ensuring the highest quality...


  • Milano, Lombardia, Italia PSI 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 Italy. 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...


  • 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...


  • Milano, Lombardia, Italia Pharmiweb A tempo pieno

    Job Title: Clinical Research Associate IIWe are seeking a highly motivated and experienced Clinical Research Associate II to join our team in Italy. As a CRA II, you will play a critical role in the success of our clinical trials, working closely with our clients and internal stakeholders to ensure the smooth execution of studies.Key Responsibilities:Conduct...


  • 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...


  • 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 key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials.Key Responsibilities:Monitor and control investigation sites to ensure compliance with trial...

Clinical Research Associate II

2 mesi fa


Milano, Lombardia, Italia Allucent A tempo pieno
Job Title: Clinical Research Associate II

We are seeking a highly skilled Clinical Research Associate II to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials.

Key Responsibilities:
  • Monitor and control investigation sites to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
  • Perform site initiation, monitoring, and closure visits to ensure adherence to study protocols and SOPs.
  • Track and supervise the collection of ongoing study data for regular project status reporting.
  • Collect and review regulatory documents as required.
  • Prepare site visit reports and telephone contact reports.
  • Maintain and update the Clinical Trial Management System (CTMS) in compliance with SOPs and study-specific directives.
  • Act as Document Owner for collected documents.
  • Participate in the start-up process, including preparing Informed Consent forms, developing study documents, and site contract management.
  • Proactively identify and mitigate issues, resolving site recruitment challenges and determining IP shipment status.
  • Act as the main line of communication between the project team and site staff.
  • Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities and facilitate oversight of study conduct at sites.
  • Identify potential logistical and practical problems and support the project team in creating solutions and contingency plans.
  • Ensure the continuous maintenance of the Trial Master File and Investigator Site File.
  • Assist the Project Manager and Clinical Team Leader in generating study-specific forms for completion by CRAs and Investigators.
  • Work with the Project Manager, Clinical Team Leader, and Study Start-Up team members to ensure authorization of regulatory documents and site contracts.
  • Attend Investigator Meetings and present at investigator meetings and study-specific training meetings.
  • Translate, coordinate translations, or review completed translations of essential documents as required.
  • Participate in feasibility and site identification activities, contacting local opinion leaders, medical consultants, or specified investigators to identify sites with potential for participation.
  • Identify documentation required for review by Regulatory Authorities and Ethical Committees, prepare Regulatory and Ethics Committee submissions, and ensure written approvals are obtained and distributed appropriately prior to Site Initiation.
  • Prepare and attend Assessment Visits with a more senior CRA, CTL, or Clinical Research Manager as required.
  • 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.
  • Assist the Project Team with day-to-day management of critical studies, including attendance at team meetings.
  • Provide secondary in-house review of CRFs (if required).
  • Support site staff in preparation for study-related site audits and inspections.
  • Report Quality Issues and support the root cause analysis, writing of, and resolution of Corrective and Preventative Actions.
  • May be assigned other tasks/activities/responsibilities related to study execution in the country.
  • May support initiatives in the country, GCO, and/or CTO to contribute to improvements and quality.
Requirements:
  • At least 2 years of experience.
  • Skills to mentor and train other CRAs in a positive and effective manner.
  • In-depth knowledge of clinical trials and critical elements for success in clinical trials.
  • Ability to travel for up to 8 days on site per month, depending on project needs.
  • Strong therapeutic background.
  • Ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations, proactive identification and addressing of problems, and seeking to understand all contributing factors.
  • Ability to define and meet project requirements.
  • Flexibility for improvement and creating solutions.
  • Proven organizational abilities, excellent written and oral communication, and presentation skills.
  • Excellent team player with team building skills.
  • Strong customer focus.
  • Thorough knowledge of regulatory submission and reporting requirements and guidelines.
  • Excellent understanding of the drug development process.
Benefits:
  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.