Clinical Research Associate 2, South Korea

Role Purpose The Clinical Research Associate 2 (CRA2) is a member of the Clinical Operations group atEmerald Clinical. The Clinical Operations group is responsible for site management,monitoring tasks, and the operational support of clinical trials. The group allocates resources to projects as appropriate to assist with implementing project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs). Key AccountabilitiesCoordinate the identification, feasibility assessment, and selection of investigators andsites to undertake the trial. Complete all monitoring activities per the Monitoring Plan along with completingmonitoring visit reports, accurately and within the predetermined timeframe.

Prepare, plan, organise, and conduct site evaluation visits and report on these visits toassist in site selection. Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding thepreparation of regulatory packages, importation/exportation requirements, andupdates of Ethics Committee packages. Negotiate site budgets, coordinate for site contract execution, track invoicing, andensure 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 goodunderstanding of the protocol, investigational product, and requirements of the trial sothey 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 liaisewith Data Management and/or Quality colleagues, as needed. Adhere to the trial protocol, all applicable project-related plans, as required by theProject Training Matrix, And Other Relevant Project-specific Requirements.

Adhere to ICH/GCP and other regulatory guidelines and requirements asrelevant to the trial including reporting of subject safety - adverse/seriousadverse events, protocol violations/deviations, and liaise with safety colleaguesas 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 escalateas appropriate. Collect, review, and approve essential documents from trial sites, to ensure qualityand 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 productAnd Other Trial Supplies Per Site/trial Requirements. Maintain trial information using the clinical trial management system and any othertracking and reporting tools for the trial. Support strategies to boost recruitment efforts. Coordinate and perform translation verification of regional language, as required or asapplicable per region. Perform project site close-out visits and other site activities including archiving, asapplicable. Mentor, coach, and train junior staff members as directed by line management.

Perform any additional responsibilities assigned by the Line Manager and/or ProjectLead. GeneralMaintain up-to-date and accurate timesheet records. Utilise all designated systems relevant to this role. Submit expenses within expected timeframes. Demonstrate understanding and adherence to Emerald Clinical’s values. Personal DevelopmentParticipate in setting objectives, performance improvement activities, andimplementation of career development plans. The CRA2 position is for those wishing to become a Senior CRA (SCRA) by followingthe CRA2 to SCRA development pathway. Training, Quality and Compliance Complete mandatory training for this role within specified timelines. Identify resources and training to support learning and development within this role.

Ensure quality control of all relevant processes and activities performed. Report and escalate identified risks and issues in areas of responsibility according toEmerald Clinical and/or project requirements. Comply with all applicable regulations, guidelines, SOPs, and project-specificrequirements. Customer Focus and TeamworkManage effective communication with key stakeholders, e. g. , Investigators, site staff,vendors, internal teams, etc. Attend and actively participate in Emerald Clinical meetings, activities, and otherinternal meetings as required. Provide input to systems, tools, and processes to support continuous improvement. Share knowledge with others to facilitate learning and development across theorganisation.

Maintain professionalism and accountability in all business activities conducted,especially when managing external stakeholders. Work Health and SafetyComply with Work Health & Safety (WH&S) legislation and operate in accordance withestablished organisational WH&S practices and procedures. Promote and contribute to a safe, secure environment for staff and visitorEducation And ExperienceTertiary qualifications in a related science or health care disciplinePrevious experience in clinical trials within an academic, CRO, or pharmaceuticalenvironmentCompetenciesDisplay competence in the following technical areas: ethical and participant safetyconsiderations, site start-up management, site conduct management, riskmanagement, quality management, supply management, scientific concepts andclinical research design, and issue escalation management.

Demonstrate competence in the following business skill areas: negotiation andconflict resolution, critical thinking, problem-solving, decision making, and strategicthinking. Demonstrate solid interpersonal communication, presentation skills, and flexibility towork well within a multi-disciplinary team both autonomously and with a wide range ofvarying stakeholders. Possess organisational and time management skills, which include the ability toorganise and prioritize, take initiative, and follow up independently to ensuredeliverables are met on time. Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethicaland regulatory research requirements. Possess an understanding of medical terminology and physiology.

Proficient in navigating software/systems including Microsoft Office Suite along withother project-specific management tools. Additional RequirementsAbility and willingness to travel. Ability to be flexible and adaptable in the face of changing organisational priorities andambiguous environments.