Senior In House CRA

Provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonisation (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. Expected to work independently in providing support to CRA and sites. Senior In-house CRA can have increased focus on training and development of junior staff members and can act as Lead In-house CRA. Assists with investigator recruitment activities, site feasibility and recruitment tasks. Performs ongoing essential document collection and review, maintenance, and close-out activities. Assists with sets up and maintains site-related data in applicable clinical systems and tracking milestones. Acts as site contact/liaison for study and site management issues including addressing questions, assists with managing study supplies and may support offsite central monitoring activities. Escalates issues and risks as needed. Supports investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements. Consults with project team members regarding study site issues. Provides quality review of the amended site level informed consent template. Supports on-site visit activities if needed. Assists management with the development of training materials.