Sr. Clinical Research Associate

2 settimane fa


Milan, Italia Allucent 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 Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide 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.

In this role your key tasks will include:

  • Governs quality standards for trial monitoring activities.
  • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements.
  • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
  • Collects and reviews regulatory documents as required.
  • Prepares site visit reports and telephone contact reports.
  • Maintains and updates CTMS in compliance with SOPs and study-specific directives.
  • Acts as Document Owner for collected documents.
  • May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management.
  • Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
  • Acts as the main line of communication between the project team and the site staff.
  • 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.
  • Identifies potential logistical/practical problems and supports Project team to create solutions / contingency plans, with timeframes for resolution.
  • Ensures the continuous maintenance of the Trial Master File and Investigator Site File.
  • 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.
  • 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.
  • Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings and study specific training meetings.
  • May translate, coordinate translations or review completed translations of the essential documents as required.
  • May participate in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation.
  • 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.
  • Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
  • 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.
  • Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
  • Provides secondary in-house review of CRFs (if required).
  • Supports site staff in preparation for study related site audits and inspections.
  • Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.
  • May be assigned other tasks / activities / responsibilities related to the study execution in the country.
  • May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality.
  • Must work both independently and in a team environment.

Requirements

To be successful you will possess:

  • At least three years clinical monitoring experience and/or relevant clinical trial experience.
  • Relevant life science degree / health care / nursing background and/or related degree.
  • Sound knowledge of medical terminology and clinical monitoring process.
  • Strong communication in Local and English language in both written and verbal skills.
  • Strong interpersonal and organizational skills.
  • Ability to translate guidelines, rules and regulations in clear and usable recommendations.
  • Representative, outgoing and client focused.
  • Ability to work in a fast-paced challenging environment of a growing company.
  • In-depth therapeutic and protocol knowledge.
  • Ability to travel for up to 8 days on site per month, depending on the project needs.
  • Attention to detail.
  • Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients.
  • Demonstrated ability to manage multiple projects.
  • Administrative excellence.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
  • Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues.

Benefits

Benefits of working at Allucent include:

  • 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.

Disclaimers:

  • Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
#J-18808-Ljbffr

  • Milan, Italia Psi CRO Ag A tempo pieno

    Clinical Research Associate II / Senior Clinical Research AssociateFull-timePSI 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.As a...


  • Milan, Italia ICON 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 work...


  • Milan, Italia Allucent 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 Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will independently...


  • Milan, Italia Allucent 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 Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will...


  • Milan, Italia PSI CRO A tempo pieno

    Company DescriptionPSI 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 DescriptionAs a Clinical Research Associate at PSI Italy, you...


  • Milan, Italia PSI CRO A tempo pieno

    Job DescriptionAs a Clinical Research Associate at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.Hybrid working arrangement in Milan area or homebased in other regions of ItalyResponsibilities:Conduct and report all types of...


  • Milan, Italia PSI A tempo pieno

    Job Description As a  Clinical Research Associate  at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. Hybrid working arrangement in Milan area or homebased in other regions of Italy Responsibilities: Conduct and...


  • Milan, Italia PSI CRO A tempo pieno

    Job DescriptionAs a Clinical Research Associate at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.Hybrid working arrangement in Milan areaResponsibilities:Conduct and report all types of onsite monitoring visitsBe involved in...


  • Milan, Italia PSI CRO A tempo pieno

    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 DescriptionAs a Clinical Research Associate at PSI Italy, you will enjoy a...


  • Milan, Italia AB Lavoro A tempo pieno

    Descrizione aziendaSiamo 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 pronta a...


  • Milan, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number7552Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...


  • Milan, Italia ICON Plc A tempo pieno

    Senior Clinical Research AssociateICON 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...


  • Milan, Italia AstraZeneca A tempo pieno

    At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a Clinical Research Associate (CRA) in Italy, you will play a pivotal role in channelling our scientific...


  • Milan, Italia IQVIA A tempo pieno

    Job Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Essential Functions • Complete appropriate therapeutic, protocol and clinical...


  • Milan, Italia Allucent 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...


  • Milan, Italia Allucent 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...


  • Milan, Italia IQVIA A tempo pieno

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...


  • Milan, Italia Ergomed A tempo pieno

    Job DescriptionNational Travel RequiredPerforms 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 studyIdentifies the investigators and verifies that the investigator has adequate...


  • Milan, Italia PSI A tempo pieno

    Job Description Take your career to the next level and lead challenging full-service global clinical research projects, managing the full scope of responsibilities and getting hands-on involvement in every aspect of the study. Your responsibilities will include: Management of global, multi-center clinical research projects in a variety of...


  • Milan, Italia IQVIA A tempo pieno

    The IQVIA Cardiovascular Center of Excellence, a hub of clinical innovation, is growing! We are looking for exceptional Board-Certified physicians to join our team as a Medical Strategy Lead to help us expand our Cardiovascular portfolio and advance this dynamic and rapidly expanding area of clinical development. The Cardiovascular Medical Strategy Lead...