CRA - Sponsor Aligned

divh2CRA - Sponsor Aligned/h2pCarlsbad, United States of America | Full time | Field-based | R1543442/ppJob 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./ppEssential Functions/pulliPerform 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/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/pulliBachelors Degree Degree in scientific discipline or health care preferred. Req/liliRequires at least 1 year of on-site monitoring experience. Req/liliEquivalent 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)./liliWritten and verbal communication skills including good command of English language./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/ul/div