Clinical Research Associate II / SCRA

Premier Research is looking for a Clinical Research Associate II / SCRA to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. ROLE RESPONSIBILITIES: Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines Maintains submission of expenses according to travel and expense requirements within company guidelines Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations Plans day-to-day activities for monitoring a clinical study and sets priorities per site Prepares for and conducts on-site or remote qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum Monitors with knowledge of quality/scope/timeline and budget parameters  Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member Manages query resolution process with sites and Premier Research Data Management Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Maintains an understanding of the required essential documents according to ICH/GCP Appendix C. Reviews site documents and verifies they are accurate, complete, current, and include required updates Assists project team with assessing project feasibility and recruitment, as applicable Maintains project tracking system of subjects and site information, as applicable Participates in Investigators’ Meeting as designated by the Project Manager Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts …