Assoc Site Report Specialist

Job Description

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements Essential Functions Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports. Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery. Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations. Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers. Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log. Provide coaching to CRAs to decrease the level of corrections/additions needed on reports. Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members. May take on special project assignments related to function/corporate initiatives. Qualifications Bachelors Degree Healthcare or other scientific discipline or educational equivalent Req 7-8 years of Clinical Research experience, including a minimum of 3 to 4 years on-site monitoring experience Req Or Equivalent combination of education, training and experience. Req Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications Demonstrated skill in understanding and executing complex study designs as well as multiple studies Strong written and verbal communication skills. Effective time management and organizational skills, and the ability to manage competing priorities Ability to work independently with good analytical and problem solving skills Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences High quality orientation, with a focus on attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients. Fluent in English, both spoken and written.