Clinical Research Associate, Site Management - Italy

ph3Job Overview /h3 pPerform 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. /p h3Essential Functions /h3 ul liPerform 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. /li liWork with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. /li liAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. /li liEvaluate 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. /li liManage 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. /li liEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. /li liCreate 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. /li liCollaborate and liaise with study team members for project execution support as appropriate. /li liIf applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. /li liIf applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. /li /ul h3Qualifications /h3 ul liMaster’s Degree in Life Sciences. /li liIn possession of CRA certification according to Ministerial requirements. /li liCompletion of CRA training program or prior monitoring experience. /li liBasic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). /li liGood therapeutic and protocol knowledge as provided in company training. /li liComputer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). /li liWritten and verbal communication skills including good command of English language. /li liOrganizational and problem-solving skills. /li liEffective time and financial management skills. /li liAbility to establish and maintain effective working relationships with coworkers, managers, and clients. /li /ul /p #J-18808-Ljbffr