Experienced Clinical Research Associate, IQVIA Biotech
2 settimane fa
Experienced Clinical Research Associate, IQVIA Biotech - Home based, ItalyOverviewPerform 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. ResponsibilitiesPerform 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. QualificationsUniversity Bachelor\'s Degree and Master\'s Degree in scientific discipline or health care In possession of CRA Certification as required by Ministerial Decree dated Experience in Pharma Industry, and/or Clinical Trials environment Very good computer skills including MS Office Excellent command of English language Organizational, time management and problem-solving skills Ability to establish and maintain effective working relationships with coworkers, managers, and clients Flexibility to travel Driver's license class B#J-18808-Ljbffr
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Milan, Italia Altro A tempo pienoExperienced Clinical Research Associate, IQVIA Biotech - Home based, Italy 2 days ago Be among the first 25 applicantsJob 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...
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Milan, Italia Altro A tempo pienoExperienced Clinical Research Associate, IQVIA Biotech - Home based, Italy2 days ago Be among the first 25 applicantsJob OverviewPerform 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...
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Milan, Italia Altro A tempo pienoExperienced Clinical Research Associate, IQVIA Biotech - Home based, Italy 1 day ago Be among the first 25 applicantsJob 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...
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Experienced Clinical Research Associate, IQVIA Biotech
3 settimane fa
Milan, Italia Altro A tempo pienoExperienced Clinical Research Associate, IQVIA Biotech - Home based, ItalyOverviewPerform 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. ResponsibilitiesPerform site monitoring visits (selection,...
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Clinical Research Associate, Sponsor Dedicated
2 settimane fa
Milan, Italy IQVIA A tempo pienoExperienced Clinical Research Associate, Italy Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits Supporting the development of a subject recruitment plan Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International...
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Clinical Research Associate, Sponsor Dedicated
2 settimane fa
Milan, Italia IQVIA A tempo pienoExperienced Clinical Research Associate, ItalyYour responsibilities will include:Performing site selection, initiation, monitoring and close-out visitsSupporting the development of a subject recruitment planEvaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International...
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Clinical Research Associate, Sponsor Dedicated
2 settimane fa
Milan, Italia IQVIA A tempo pienoExperienced Clinical Research Associate, ItalyYour responsibilities will include:Performing site selection, initiation, monitoring and close-out visitsSupporting the development of a subject recruitment planEvaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International...
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Clinical Research Associate, Sponsor Dedicated
2 settimane fa
Milan, Italia IQVIA A tempo pienoExperienced Clinical Research Associate, ItalyYour responsibilities will include:Performing site selection, initiation, monitoring and close-out visitsSupporting the development of a subject recruitment planEvaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International...
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Clinical Research Associate, Sponsor Dedicated
2 settimane fa
Milan, Italia IQVIA A tempo pienoExperienced Clinical Research Associate, ItalyYour responsibilities will include:Performing site selection, initiation, monitoring and close-out visitsSupporting the development of a subject recruitment planEvaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International...
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Clinical Research Associate, Site Management
4 settimane fa
Milan, Italy IQVIA A tempo pienoJob 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 research...
