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Senior Clinical Research Associate Job Seoul South Korea,  

MSD (company)


Posted on : 16 May 2019

Project Description

Requisition ID: CLI008573

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 Subjectsright, 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
    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



 



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.

  • 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

  • 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
Qualifications

B.A./B.S.
required with strong emphasis in science and/or biology



Min. 5 years of direct site
monitoring experience in a bio/pharma./CRO. 



Note - No compromise on min monitoring
experience



Job: Clinical Research - Clin Ops
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Research Associate, Clinic, Clinical Research, Medical Research, Research, Healthcare

Locations

Jung-gu, 11, KR

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