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Job Description The role of Clinical Research Associate 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, our 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: Performs clinical study site management / monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.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.Supports and/or leads audit/inspection activities as needed.Experience Requirements: Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Educational Requirements: B.A. / B.S. with strong emphasis in science and/or biology.
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 actions.Behavioral Competency Expectations: Effective time management, organizational, and interpersonal skills, conflict management, problem-solving skills.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.Positive mindset, growth mindset, capable of working independently and being self-driven.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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