Experienced CRA, Sponsor Dedicated

divh2Experienced CRA, Sponsor Dedicated/h2pZaventem, Belgium | Full time | Home-based | R1513056/ppPerform 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./ppRole Location: Belgium/ppEssential Functions/pulliPerform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice./liliWork with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability./liliAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues./liliEvaluate 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./liliManage 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./liliEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigators Site File (ISF) is maintained in accordance with GCP and local regulatory requirements./liliCreate 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./liliCollaborate and liaise with study team members for project execution support as appropriate./liliIf applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis./liliIf applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement./li/ulpQualifications/pulliRequires at least 2 years of on-site monitoring experience./liliWritten and verbal communication skills including excellent command of English and Dutch, as well as at least B1 level of French language./liliBachelors Degree Degree in scientific discipline or health care preferred. Equivalent combination of education, training and experience may be accepted in lieu of degree./liliGood knowledge of, and skill in applying, applicable clinical research regulatory requirements. i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines./liliGood therapeutic and protocol knowledge as provided in company training./liliComputer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)./liliOrganizational and problem-solving skills./liliEffective time and financial management skills./liliAbility to establish and maintain effective working relationships with coworkers, managers, and clients./li/ulpIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide./ppIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism./p/div