Senior Clinical Research Associate Job Seoul South Korea,
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
- 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
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
- 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
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
- Fluent in Local Languages
and English (verbal and written) and excellent communication skills,
including the ability to understand and present technical information
- 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
- Hands on knowledge of
Good Documentation Practices
- Proven Skills in Site
Management including independent management of site performance and
- 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
- 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
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
Job: Clinical Research - Clin Ops
Employee Status: Regular
Number of Openings: 1
Shift (if applicable):
Company Trade Name: MSD
Job Segment: Research Associate, Clinic, Clinical Research, Medical Research, Research, Healthcare
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