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Senior Clinical Research Associate Job Seoul South Korea,  

MSD (company)


Posted on : 16 May 2019

Project Description

Requisition ID: CLI008547

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

Locations

Jung-gu, 11, KR

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