Site Management Associate specifically trained in many late phase research study designs. Direct late phase study design experience in patient registries. Responsibilities include site recruitment, essential document collection and review, regulatory submissions, site management, and data review.

Provide support to sites and CRAs directly to process and resolve queries and requests as needed. Serve as primary in-house contact for sites and investigators participating in studies. Become familiar with the principles of and assist with investigator recruitment. Conduct and complete remote site management activities, with support as needed, according to applicable SOPs and the Study Monitoring Plan. Contact clinical sites for specific requests, including enrollment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action item resolution or other sponsor specific tasks.

Works with a collaborative and successful team on a daily basis to support the clinical trial management, project management, and CRA teams as well as sites and vendors with operational activities. • Provides administrative support to various projects, maintain and track clinical study documentation and collect relevant study information.• Maintain and oversee study files in the Trial Master File. • Coordinate blast emails• Prepare sponsor meeting agendas and distribute to the team• Participate in study meetings, complete meeting minutes, and distribute the finalized minutes to the team. • Monitor study status through reports and trackers • Monitor queries and follow-up with sites• Grant vendor access to the study team and site members• Perform other duties as assigned