• Oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. • Focus on coordinating clinical trial monitoring delivery, resolving issues, and developing team capability. • Lead site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines. • Serve as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance. • Ensure the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations. • Mentor and provide guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies. • Collaborate with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.

• Oversight of monitoring effectiveness • Implements various types of oversight encounters and activities • Completes Sponsor Oversight Visit reports consistently • Utilizes a risk-based approach to review critical to quality items • Creates Study Specific Oversight Plans (SSOPs) for aligned trials • Troubleshoots and uses alternative and innovative approaches to solve problems • Builds relationships with investigators and site staff in region

• As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. • You will build and maintain relationships with clinical sites and investigators. • Your focus will be on subjects’ rights, safety and well-being and quality of data compliance. • Responsibilities will include conducting and reporting all types of onsite monitoring visits, driving the study startup phase, performing CRF reviews, source document verification and query resolution.

• Serve as main CTI contact for assigned study sites • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP • Assist with study start-up activities, including feasibility, pre-study activities and site selection • Collect, review and track essential/regulatory documents • Participate in and complete all general and study specific training as required • Participate in investigator, client and project team meetings • Create and implement subject enrollment strategies for assigned study sites • Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager • Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan • Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP • Assist with project-specific activities as member of Project Team • May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.) • May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures • Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. • Provide regular updates to Sponsor/ Client • Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments • Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans • Identify site issues and implement corrective actions or escalate as appropriate • Liaise with Clinical Data Management for data cleaning activities • Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary