Site Management Administrator
- Experience Level
- Experienced (non-manager)
The PRA, we know that our people are our greatest strength, so we work hard to hire the very best. If you join our team, you can expected to be challenged, rewarded and nurtured.We have a dynamic and loyal workforce, a culture that values individuality and innovation and an ongoing commitment to employee growth and development. The result? A dynamic and loyal workforce who take pride in the their work on clinical development which changes lives.
The Site Management Administrator 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. ICH-Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as primary point of contact for study sites.
- Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
- Completes essential document collection and review throughout the study lifecycle inclusive of site activation. Organizes and maintains site clinical trial master file (TMF) documents.
- Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
- Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies
- Escalates issues and risks as needed.
- Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
- Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
- Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
- Bachelor’s degree or international equivalent
- Basic knowledge of the drug development process
- Working knowledge and practical utilization of ICH-GCP and applicable regulatory requirements
- Good spoken and written communication skills
- Good presentation skills
PRA is an EEO AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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