CRAI/CRAII (Gauteng) Sponsor dedicated

📋 Description

• • Conducts site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
• • Verifies that informed consent processes are properly documented for all subjects/patients and ensures confidentiality and protection of patient data.
• • Performs source document review to confirm accuracy and completeness of clinical data entered into case report forms (CRFs), resolving queries remotely and on-site within agreed timelines.
• • Monitors and verifies investigational product (IP) inventory, storage, security, dispensing, and administration in alignment with protocol and regulatory requirements.
• • Reviews and reconciles Investigator Site Files (ISF) with the Trial Master File (TMF), ensuring all essential documents are complete, accurate, and archived per local regulations.
• • Documents all monitoring activities through trip reports, follow-up letters, communication logs, and other required project documentation in accordance with SOPs and Clinical Monitoring/Site Management Plans.
• • Supports subject recruitment and retention strategies, and enters tracking data into systems to monitor site status and action items to resolution.
• • Manages site-level activities to meet project timelines, budgets, and deliverables, adapting quickly to shifting priorities and requirements.
• • Serves as primary liaison between sponsor and site personnel, ensuring all site staff are trained and compliant with regulatory and company standards.
• • Prepares for and participates in Investigator Meetings, sponsor meetings, and clinical training sessions as required by the project.
• • Ensures sites are audit-ready and supports preparation for and follow-up of regulatory audits.
• • Provides mentorship and training to junior Clinical Research Associates (CRAs), including conducting training and sign-off visits as assigned.
• • For Real World Late Phase (RWLP) roles: Supports sites throughout the entire study lifecycle from identification to close-out; performs chart abstraction and data collection; collaborates with sponsors, medical science liaisons, and local country staff; identifies potential sites based on local treatment patterns and HCP networks; develops country-specific informed consent forms; works with RWLP Regulatory team to apply updated regulatory information; participates in bid defense meetings.
• • Applies knowledge of local regulations and organizational procedures to ensure proper relabeling, importation, and return of investigational products.
• • Utilizes electronic data capture systems and other software tools to support clinical data review and compliance with monitoring requirements.
• • Escalates serious issues to the project team promptly and develops actionable plans to address site performance or compliance risks.
• • Maintains current knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs to ensure consistent adherence across all monitoring activities.