In-House Clinical Research Associate II / Senior In-House CRA

The In-house CRA II 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 Harmonization (ICH) -Good Clinical Practice (GCP), , and country/region-specific regulations). Acts as point of contact for study sites. Essential functions include assisting with investigator recruitment, identifying study sites by performing site feasibility and recruitment tasks, scheduling meetings, and preparing Investigator Site Files. They perform ongoing essential document collection and review, organizing and maintaining site level data in the trial master file (TMF) ensuring compliance with ICH/GCP guidelines and local regulations. They also assist with data review, database closure as per study plans, and study tracking via CTMS or other systems, documenting site and Sponsor contact. Minimum Requirements include a Bachelor's degree or equivalent, minimum of 2 years of relevant experience, high proficiency in Microsoft Office, customer service demeanor, and fluency in English. Preferred qualifications include solid experience in clinical research and excellent organizational skills.