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포지션: Senior. Clinical Research Associate
계열사: 한국얀센 (Janssen)
근무지: 서울시 용산구
근무 형태: Regular
A Senior. Clinical Research Associate (Site Manager II) in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology studies. A Site Manager II is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM) and Global Trial leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.
A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.
- Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
- Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies. Responsible for the implementation of ARBM (Analytical Risk Based Monitoring) model at the site level when applicable. Monitors study progress at site using study specific systems and available reports/dashboards.
- Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
- In collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensures that clinical drug supplies are appropriately handled, administered, and stored. Ensures strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried accounted and returned as applicable including maintenance of accurate and complete documentation.
- Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
- Ensures accuracy, validity and completeness of data collected at trial sites. Ensures appropriate measures are in place for maintenance of the blind when applicable.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/ Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
- Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
- Fully documents trial related activities with respect to study monitoring. Writes visit reports and follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
- Reviews Investigator Site File for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
- Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
- Attends regularly scheduled team meetings and trainings.
- Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.
- Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- Prepares trial sites for close out, conduct final close out visit.
- May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
- May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
- Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments
- Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.
- Coordinates site level lessons learned activities.
- Acts as a subject matter expert in site management practices
- Assigned as a coach and mentor to less experienced SMs, as needed and may perform accompanied site visits as delegated by FM
- Will lead and/or contributes to process improvement and training, as needed
- Will Lead and/or participates in special initiatives as assigned
- Will assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert.”
- This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Primary Reporting Structure: Reports to Functional Manager (FM).
Primary interfaces: FM, CTAs, TMs, SMs, PIPS, SIPS, Site Strategic Leads (SSLs), GTLs, Study Responsible Physicians (SRP), Quality & Compliance Manager/Specialist, Local Safety Officer
Other Internal Interfaces: Contract and Compliance Services (CCS), GPLs, TA representatives, Integrated Data Analytics and Reporting (IDAR), Bioresearch Quality and Compliance (BRQC), ED&CP Head/US ED&CP Head, ED&CP Business Operations & Quality Leader and others as required
External Interfaces: Investigational Site Staff and others as required
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- A minimum of 3 years of clinical trial monitoring experience is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility. Experience in monitoring ED&CP studies is preferred.
- Specific therapeutic area experience/knowledge may be required. Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional/regular overnight stay away from home depending on the region.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills.
- Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
- Ability to work on multiple trials in parallel in different disease are
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