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 include performing 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; working with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability; administering protocol and related study training to assigned sites and establishing regular lines of communication with sites to manage ongoing project expectations and issues; evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations and escalating quality issues as appropriate; managing 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; ensuring copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verifying that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements; creating and maintaining 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; collaborating and liaising with study team members for project execution support as appropriate; and if applicable, supporting development of project subject recruitment plan on a per site basis and site financial management according to executed clinical trial agreement and retrieving invoices according to local requirement. Qualifications include a Bachelor's Degree in scientific discipline or health care preferred, at least 1.5 years of on-site monitoring experience, good knowledge of clinical research regulatory requirements (GCP and ICH guidelines), good therapeutic and protocol knowledge, computer skills including proficiency in Microsoft Word, Excel and PowerPoint, written and verbal communication skills, organizational and problem-solving skills, effective time and financial management skills, and ability to establish and maintain effective working relationships.
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