한국엠에스디(유)
공고
2020년 10월 11일
위치
서울,
카테고리
CRA  
채용 형태

Description

업무 내용 :

한국 MSD의 임상부서인 GCTO팀에서 CRA로 근무해주실분을 다수 모집합니다.

지원자격은 Global monitoring 경력이 있으신 분(Oncology study 선호)입니다. (최소 2년의 경력 요구)

관련하여 궁금한 점이 있으신 분들께서는 kr_recruit@merck.com 으로 문의 주십시오지원 방법은 하단의 내용 확인 부탁드립니다.

 

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:
  • 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 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

 

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.
  • Works with high quality and compliance mindset

 

CRA 지원자격:

-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 preferred

로그인 이후 지원하실 수 있습니다.

관련 채용공고

글로벌cro Sr. cra   서울, new
2020년 10월 20일
2020년 10월 11일