Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; escalates serious issues and develops action plans with guidance
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Verifies the process of obtaining informed consent and demonstrates diligence in protecting subject/patient confidentiality
Assesses factors affecting subject/patient safety and clinical data integrity such as protocol deviations and pharmacovigilance issues
For the Clinical Monitoring/Site Management Plan (CMP/SMP): assesses site processes, conducts Source Document Review of site source documents and medical records, verifies required clinical data entered in CRFs is accurate and complete
Applies query resolution techniques remotely and on site; utilizes hardware and software to support clinical project data review and capture; verifies site compliance with electronic data capture requirements
May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensation and administration per protocol
Reviews and reconciles Investigator Site File (ISF) with the Trial Master File (TMF) and ensures archiving of essential documents per local guidelines
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
Supports subject/patient recruitment, retention and awareness strategies and enters data into tracking systems to manage observations and action items
Manages site-level activities, communication, scope, budgets and timelines to meet project objectives; acts as liaison with project site personnel or in collaboration with other CRAs/CMA
Ensures training and compliance of assigned sites and site team members; prepares for and attends Investigator and sponsor meetings and participates in global project meetings and clinical training
Provides guidance towards audit readiness standards and supports audit preparation and follow-up actions
For Real World Late Phase (Site Management Associate I business card title): supports site lifecycle from identification through close-out, chart abstraction and collaboration with sponsor affiliates and local country staff
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis
Compliance with site-specific requests for medical or personal information for facility access (US sites) as a condition of employment
Knowledge of local requirements for real world late phase study designs
Chart abstraction activities and data collection experience
Collaboration with Sponsor affiliates, medical science liaisons and local country staff
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture and employee well-being focus
Exposure to emerging technologies, data, science and knowledge sharing
Diversified career paths and employment opportunities
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