글로벌 헬스케어 기업인 한국MSD는 1994년 설립된 이후 우수 의약품과 전문 의학정보를 제공 해왔습니다. 건강한 세계를 만들고자 노력하는 기업 비전을 실현하며 한국인의 질병치료와 건강증진을 위해 꾸준히 노력하고 있습니다. 또한 The Fortune지가 선정한 미국에서 "가장 존경받는 기업"으로 11년 연속 수상한 바 있는 세계적인 기업입니다.
Clinical Research Associate 0명 모집
한국 MSD의 임상연구부에서 Clinical Research Associate 를 채용합니다. Global study와 Oncology monitoring 경력이 필수로, 해당 경력 보유하신 분들을 선호합니다.
지원을 원하실 경우 인https://jobs.msd.com/gb/en/job/R4164/CRA 로 자유이력서를 첨부하여 지원해주세요.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.•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: o Data generated at site are complete, accurate and unbiased o 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 CRM, PLM and RCPM. •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
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
Behavioural 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. •Works with high quality and compliance mindset
B.A./B.S. required with strong emphasis in science and/or biology
Min. 2 years of direct site monitoring experience in a bio/pharma./CRO.