The Site Management Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, in-house site management, and data review activities in accordance with the study protocol, client and/or PRA standard operating procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, and country/region specific).
The Lead Site Management Associate (Level 3 - Advanced) will directly oversee the management of study sites for assigned studies, and coordinate and provide oversight for all activities of the Site Management Associates to ensure all tasks meet client and PPA expectations, are delivered in compliance with the late phase study design. Works with the OTL to provide oversight for the study team. For studies which require minimal or no on-site monitoring, the Lead SMA may act as the primary lead for the clinical study team. The Lead SMA contributes to Business Development activities by participating in proposals and bid defenses, as required.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.