Job Summary:

The Senior Centralized Visit Report Reviewer serves as a member of a project team reviewing and approving site monitoring visit reports. Leveraging their experience, the SCVRR works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the SCVRR may mentor junior CVRRs, and may support the development of processes, procedures and other documentation to ensure a high functioning team.

Essential Job Functions:

Performs review of clinical monitoring visit reports for allocated projects ensuring consistency as per annotated report, across protocols and SOPs. Liaises with clinical monitoring staff for prompt monitoring visit report review submission and approval as per the Precision/Sponsor SOP timelines. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations. Uses experience and expertise to evaluate Investigator and Site performance and/or ability to adhere to study and protocol requirements as ascertained from information in monitoring visit reports and associated electronic data systems. Proactively escalates areas of concern and recommends plans of action. Acts as subject matter expert in the use of CTMS for management of site monitoring visit report review, production of key metrics, addressing action items, and other content to improve project-level and organizational performance. Ensures open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards Attends internal project meetings and actively provides suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends Leads in the communication of trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety with CTM oversight and support. Ensures all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner Serves as CVRR subject matter expert in the provision of insights recommendations and development of risk management plans to minimize impact on project objectives,  deliverables, patient safety and consistent improvement in metrics. Actively supports staff with change management. Is involved in the development of reporting, tools, and processes to that can be used by the CVRR team to identify and address study performance concerns early.  Identifies methods for performing work that can be improved through process change and/or better documentation. Serves as subject matter expert on the visit reports, trends, issues and actions to support company, client, and federal/local regulatory requirements/audit responses as needed Works with study leadership  to identify areas of improvement in the performance of site monitoring, through the identification of trends, common issues, and staff processes. Performs other duties as assigned by management

Qualifications:

Bachelor’s Degree in a life science-related field (nursing, medical, physiology, pharmacy, etc.) or relevant/equivalent combination of education, training, and experience Minimum 6 years experience in clinical monitoring, clinical trial management  or equivalent Working knowledge of ICH GCP guidelines and the clinical development process

Other Required:

Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Ability to work in a team or independently as required Excellent skills in reviewing and/or approving clinical monitoring visit reports Excellent ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Ability to mentor junior team members, as needed.