Senior Clinical Research Associate

Emerald Clinical

Senior Clinical Research Associate coordinating and managing clinical trials at Emerald Clinical in South Korea. Involves site management, monitoring, and regulatory compliance activities.

Posted 6/19/2026full-timeSeoul • 🇰🇷 South KoreaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
Prepare, plan, organise, and conduct site evaluation visits and report on these visits to assist with site selection.
Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
Prepare, plan, organise, and conduct site initiation visits.
Develop and maintain appropriate monitoring tools and project-specific documents.
Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
Manage trial sites utilising both on-site and off-site activities including:
- Verification of quality, accuracy, completion, and timeliness of data.
- Ensure complete and efficient resolution of data queries, audits, issues, and liaise with Data Management and/or Quality colleagues, as needed.
- Adhere to the trial protocol, all applicable project-related plans, as required by the project training matrix, and other relevant project-specific requirements.
- Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of subject safety - adverse/serious adverse events, protocol violations/deviations, and liaise with safety colleagues as needed.
- Ensure targets, metrics, and quality are maintained per trial expectations.
- Identify risks associated with e.g., clinical trial design, privacy and confidentiality, clinical trial misconduct, and take action to mitigate risk proactively and to escalate as appropriate.
Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
Reconcile contents of in-house TMF and site’s Investigator Site Files.
Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
Support strategies to boost recruitment efforts.
Coordinate and perform translation verification of regional language, as required or as applicable per region.
Perform site close-out visits and other site activities including archiving, as applicable.
Mentor, coach, and train junior staff members as directed by line management.
Perform any additional responsibilities assigned by the Line Manager and/or Project Lead.

Requirements

What you’ll need

Educated to degree level in pharmacy, medical, nursing, biological science, or other health-related disciplines preferred or equivalent relevant experience.
More than 5 years experience in clinical trial monitoring and/or site management within a contract research organization, or pharmaceutical environment.
Experience with Oncology or Renal trials is highly regarded.
Displays high competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
Demonstrate high competence in the following skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
Demonstrates solid interpersonal communication skills, presentation skills, is flexible, and can work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders.

Benefits

Comp & perks

Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience.
Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role.
Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients.

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial monitoringsite managementrisk managementquality managementnegotiationproblem-solvingdecision makingstrategic thinkingscientific conceptsclinical research design

Soft Skills

interpersonal communicationpresentation skillsflexibilitycritical thinkingconflict resolutionautonomyteam collaborationmentoringcoachingtraining