Job Description The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities include, but are not limited to: Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate, and unbiased. Subjects' right, safety, and well-being are protected. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance, and study close-out. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance. Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head, and CRD as needed. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas, and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. Manages and maintains information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines. Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor, and sharing best practices as appropriate/required. Supports and/or leads audit/inspection activities as needed. Performs co-monitoring visits where appropriate. Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Ability to travel domestically and internationally approximately 65%-75% of working time. Expected traveling ~2-3 days/week. CORE Competency Expectations: Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Hands-on knowledge of Good Documentation Practices. Proven Skills in Site Management including management of site performance and patient recruitment. Demonstrated high level of monitoring skill with independent professional judgment. Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyze data/metrics and act appropriately. Capable of managing complex issues, works in a solution-oriented manner. Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills. Demonstrated high level of monitoring skill with independent professional judgment. Able to work highly independently across multiple protocols, sites, and therapy areas. High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. Demonstrates commitment to Customer focus. Works with high quality and compliance mind-set. Positive mindset, growth mindset, capable of working independently and being self-driven. Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: B.A./B.S. with strong emphasis in science and/or biology. Employee Status: Project Temps (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/25/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. #J-18808-Ljbffr