Job Title: Clinical Trial Associate
Job Location: Korea, Seoul
Job Overview:
The Clinical Trial Associate, in collaboration with global internal and external study team members, supports all phases of the study under departmental and/or study team supervision. Duties may include administrative functions such as minute taking, data entry, tracking, scanning/copying, binder creation, and supply distribution. Includes participation in study meetings, essential document review and Trial Master File (TMF) processing. May include budget negotiation, fee tracking, and amendment processing. Supports multiple studies based on scope. Meets defined chargeability expectations for position.
Job Duties and Responsibilities:
Under close supervision:
Participates in internal and external meetings, provides updates as required, may take minutes or assist in action/decision log maintenanceSupports regulatory inspections and/or audits as requiredInterfaces with vendors as requiredProcures, maintains, and ships study documents, supplies, and materials in compliance with Caidya Standard Operating Procedures (SOPs) and study-specific processesMaintains study servers and portals where applicableTracks documents and study status in applicable tracking systemsReports document collection and tracking issues to functional lead and/or study team on a regular basisIdentifies, manages, escalates where appropriate, and resolves site issues effectivelyAssists with ad hoc issue resolution as directed and delegatedCommunicates functional area study status and provides associated reports to the study team as appropriateSubmits documents and/or files directly within TMF, may conduct document review and/or support with document query resolutionPerforms regular support of site level document collection via Clinical Research Associate (CRA) and/or directly from site where requested Assists ongoing completeness review of assigned content within TMFConducts designated final site level TMF review and provisions partial final document collection expectations by CRA at Close Out VisitSupports study team with functionality and use of TMF in accordance with study-specific TMF Plan, Caidya SOPs and study-specific processesReviews and maintains study Outlook folders as applicable, provides correspondence to sites, sponsors, and study team members as needed Performs other study-specific duties as assigned by Project Manager as agreed by departmental management and in accordance with scopeConducts other duties as assigned by departmental management (e.g. Team Leader, Manager, Director)Where regionally required:
Conducts fee tracking and/or data entryAssists with amendment tasks including site notification, supply shipment, budget update, Institutional Review Board/Ethics Committee submission, and Informed Consent Form reviewSupports safety letter distribution to sites and IRB as required
Supervisory Responsibilities: No direct supervisory responsibilities.
Job Requirements:
EducationCollege/University graduate preferred, healthcare or life science degree a plusEquivalent combination of education and relevant work experience consideredExperiencePrior relevant work experience preferredSkills/CompetenciesStrong English language written and verbal communication skillsStrong interpersonal skillsTeam-oriented and a strong team playerStrong computer skills, including Microsoft OfficeInterest in learning medical terminologyExceptional attention to detailHighly organizedAble to work in a dynamic, changing environmentDemonstrates honesty, trust, fairness, cooperation, self- control, and flexibilityCapabilitiesMinor lifting, < 30 lbs.Must work from regional-office location#LI-XX1 V2
The company will not accept unsolicited resumes from third party vendors.
Share