[Oncology]Clinical Research Associate
3주전에
Typical Accountabilities:
Contributes to the selection of potential investigators. In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. Actively participates in Local Study Team (LST) meetings. Contributes to National Investigators meetings, as applicable. Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. Updates CTMS and other systems with data from study sites as per required timelines. Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. Ensures data query resolution in a timely manner. Works with data management to ensure robust quality of the collected study data. Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP. Follows up on outstanding actions with study sites to ensure resolution in a timely manner. Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required. Assists site in maintaining inspection ready ISF. Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD. Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF. Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). Ensures compliance with local, national and regional legislation, as applicable. Collaborates with local MSLs as directed by LSAD or line manager.Competencies and Skills:
Ability to deliver quality according to the requested standards. Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills. Good analytical and problem solving skills. Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. Good cultural awareness. Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. Team oriented and flexible; ability to respond quickly to shifting demands and opportunitiesDate Posted
09-4월-2024Closing Date
-
Seoul, 대한민국 Amgen 풀타임Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines and...
-
Seoul, 대한민국 Amgen 풀타임Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines and...
-
Seoul, 대한민국 Amgen 풀타임Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6 We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. Qualifications • CRA 0.5FTE + Local PM 0.5FTE • Minimum 1 years of PM experience required • Oncology experience preferred • Strong communication skills in English both written and verbal Essential Functions • Perform site...
-
Seoul, 대한민국 IQVIA 풀타임Essential Functions• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Work with sites to adapt, drive and track subject recruitment plan in line...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...
-
Seoul, 대한민국 IQVIA 풀타임Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive and track subject recruitment plan in...
-
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving clinical trials and providing medical expertise? Are you a seasoned medical professional with expertise in clinical trials and therapy areas such as Cardiovascular disease, Chronic Kidney Disease, Liver Disease, inflammation, Alzheimer’s disease, and emerging therapy areas? If so, we have an exciting opportunity for you...
-
Seoul, 대한민국 Constituency Management Group 풀타임Weber Shandwick Korea is seeking a highly motivated individual who is passionate about communications and excels in a fast-paced, dynamic environment. The ideal candidate will play a crucial role in supporting our global and domestic healthcare and pharmaceutical clients in various communications-related projects.As an Associate/Senior Associate you will be...
-
Research Associate
1주일전에
Seoul, 대한민국 Citi 풀타임The Research Associate is a developing professional role. Deals with most problems independently and has some latitude to solve complex problems. Integrates in-depth specialty area knowledge with a solid understanding of industry standards and practices. Good understanding of how the team and area integrate with others in accomplishing the objectives of the...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview Associate Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Project Lead is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview Serve as Data Operations Coordinator (DOC) Essential Functions • Manage delivery of projects through full data management study life-cycle (with minimal guidance). • With guidance from DTL or Manager, manage project timelines and quality. • Determine resource needs. • Identify out-of-scope work. • Serve as Data Operations...
-
Seoul, 대한민국 Thermo Fisher Scientific 풀타임: Build strong understanding of new customers and their marketplaces through a broad range of information sources, identify and lead new business opportunities with the customers. Discovering new business opportunities in areas such as CGT and other new modalities and expanding market awareness of PSG's services. Qualify any potential business...
-
Associate Consultant
4주전에
Seoul, 대한민국 IQVIA 풀타임Job Overview Provides high quality, timely development and on-time input to solutions for service delivery, managed services, or implementation oriented client projects. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions to leading small teams. Contributes to meeting client...
-
Seoul, 대한민국 IQVIA 풀타임Responsibilities • Carry out work relating to the HEOR business areas (longitudinal retrospective study using internal or external big data, longitudinal prospective observational study, cross-sectional survey of patients/healthcare provider/or payers, patient reported outcome report, etc) • Work with supervision, indepently and/or as part of a project...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview • Provides high quality, on-time input to client projects in the life sciences field. Assignments typically require analysis and problem solving within an established framework. • Serves as a Lead Medical Writer for late phase studies of Real-World Solutions team. Prepares assigned documents in accordance with IQVIA Standard Operating...
-
Seoul, 대한민국 Marken 풀타임Description Title: Customer Service Associate Job Purpose: To provide an enhanced level of customer services and operational support. Customer Services agent will deal with shipment specific and other service-related issues. Main Duties and Responsibilities: To monitor all shipments on a daily basis to ensure that shipments are collected...
-
Seoul, 대한민국 Lilly 풀타임At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Seoul, 대한민국 IQVIA 풀타임Responsibilities • Carry out work relating to the HEOR business areas (longitudinal retrospective study using internal or external big data, longitudinal prospective observational study, cross-sectional survey of patients/healthcare provider/or payers, patient reported outcome report, etc) • Work with supervision, indepently and/or as part of a...
