Experienced Clinical Research Associate, Site Management

4 settimane fa

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 with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

  • Clinical Research Associate, Site Management

    2 mesi fa

    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...

  • Clinical Research Associate, Site Management

    4 settimane fa

    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...

  • Clinical Research Associate – Italy

    3 mesi fa

    Milan, Italia Excelya A tempo pieno

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of...

  • Clinical Research Associate – Italy

    4 settimane fa

    Milan, Italia Excelya A tempo pieno

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of...

  • Clinical Research Associate II

    4 settimane fa

    Milan, Italia Pharmiweb A tempo pieno

    Clinical Research Associate II (CRA II) or Senior Clinical Research Associate (SCRA) at ClinChoice (View all jobs) Italy ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our...

  • Clinical Research Associate II

    4 settimane fa

    Milan, Italia Pharmiweb A tempo pieno

    Clinical Research Associate II (CRA II) or Senior Clinical Research Associate (SCRA)at ClinChoice (View all jobs)ItalyClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house...

  • Clinical Research Associate

    1 mese fa

    Milan, Italia Amaris Consulting A tempo pieno

    Job description Amaris Consulting is a leading global pharmaceutical and clinical research organization dedicated to advancing healthcare through innovative research and development. Our team is composed of passionate professionals committed to improving patient outcomes and advancing medical science. Position Overview:...

  • Clinical Research Associate

    4 settimane fa

    Milan, Italia Amaris Consulting A tempo pieno

    Job description Amaris Consulting is a leading global pharmaceutical and clinical research organization dedicated to advancing healthcare through innovative research and development. Our team is composed of passionate professionals committed to improving patient outcomes and advancing medical science. Position Overview:...

  • Clinical Research Associate II

    1 mese fa

    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...

  • Clinical Research Associate II

    1 mese fa

    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...

  • Clinical Research Associate II

    4 settimane fa

    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...

  • Clinical Research Associate II

    4 settimane fa

    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...

  • Clinical Research Associate

    3 settimane fa

    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...

  • Clinical Research Associate II

    1 mese 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 Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...

  • Clinical Research Associate II

    4 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 Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...

  • Clinical Research Associate II

    1 mese 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 Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...

  • Clinical Research Associate II

    4 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 Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...

  • Sr. Clinical Research Associate

    2 mesi 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...

  • Sr. Clinical Research Associate

    2 mesi 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...

  • Sr. Clinical Research Associate

    4 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...