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's policies and procedures, quality standards and adverse event reporting requirements internally and externall. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of 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.ResponsibilitiesDevelops 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.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 problemsWorks in partnership internally 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.Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.Supports and/or leads audit/inspection activities as needed.Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.QualificationsDegree in science and/or with relevant work experience in direct site management (monitoring) in bio/pharma/CRO.Required Experience and Skills:Fluent in Local Language and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.Demonstrated ability to mentor/lead.Hands on knowledge of Good Documentation Practices.Proven Skills in Site Management including independent management of site performance and patient recruitment.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, also in a virtual environment.Experience with conducting site motivational visit designed to boost site enrollment.Performs root cause analysis and implements preventative and corrective action.Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.#J-18808-Ljbffr
