Join us in our mission to INVENT the future. Let’s be part of
our team of dedicated, energetic individuals who are committed to being the
most trusted supplier of pharmaceuticals and health products worldwide. Apply
now as Senior Clinical Research Associate to be based in South Korea.
Our Clinical and Pharmacovigilance teams manage studies to provide
the safety and efficacy data required for regulatory approval of potential new
drugs, vaccines and new indications for existing products. We ensure we conduct
high quality clinical trials by integrating state-of-the-art technology and
applying rigorous scientific and ethical standards.
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
o Subjects’ right, safety and well-being are
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,
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
Supports and/or leads audit/inspection activities as
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 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
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
· Works effectively in a matrix multicultural
environment. Ability to establish and maintain culturally sensitive
· Demonstrates commitment to Customer focus.
with high quality and compliance mindset
B.A./B.S. required with strong emphasis in science
Min. 5 years of direct site monitoring experience
in a bio/pharma./CRO.
Note - No compromise on min
We are a research-driven biopharmaceutical company. Our mission is
built on the simple premise that if we “follow the science” and that great
medicines can make a significant impact to our world. And we believe that a
research-driven enterprise dedicated to world-class science can succeed by
inventing medicine and vaccine innovations that make a difference for patients
across the globe.
Who we are
Merck & Co., Inc.,
Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada
& Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin
America & Asia Pacific. We are a global biopharmaceutical leader with a diverse
portfolio of prescription medicines, oncology, vaccines and animal health
We are driven by our
purpose to develop and deliver innovative products that save and improve lives.
With 69,000 employees operating in more than 140 countries, we offer state of
the art laboratories, plants and offices that are designed to Inspire our
employees as we learn, develop and grow in our careers. We are proud of our 125
years of service to humanity and continue to be one of the world’s biggest
investors in Research & Development.
What we look for
In a world of rapid
innovation, we seek brave Inventors who want to make an Impact in all aspects
of our business, enabling breakthroughs that will affect generations to come.
We encourage you to bring your disruptive thinking, collaborative spirit and
diverse perspective to our organization. Together we will continue Inventing
For Life, Impacting Lives while Inspiring Your Career Growth.
are proud to be a company that embraces the value of bringing diverse,
talented, and committed people together. The fastest way to breakthrough
innovation is when diverse ideas come together in an inclusive environment. We
encourage our colleagues to respectfully challenge one another’s thinking and
approach problems collectively for the common good. We are an equal opportunity
employer, committed to fostering an inclusive and diverse workplace.