Research Analyst

• Run investigations where specific concerns are raised regarding images, data, data analysis, and the derived results and conclusions, and validate concerns using a range of tools and techniques
• Use scientific comprehension to provide analysis and advice for in-house editorial teams to determine whether manuscripts still under consideration are suitable for publication, and post-publication to recommend a course of action such as correction, expression of concern or retraction through decision quality
• Communicate effectively to understand and express complex ethics concepts, and clearly and concisely explain cases, both in writing and via video call, to internal and external stakeholders, such as Publishing Editors, Editors-in-Chief, Editorial Directors, Society stakeholders and Authors
• Serve as an escalation point for Research Integrity Advisers within the Resolutions team for complicated cases requiring expertise regarding image or data integrity
• Process multiple “Large cases” (involving multiple, related articles) concurrently, working as a project lead and collaborating with the Support team and Associate Research Integrity Advisers
• Use your knowledge of the case to streamline processes to drive them to resolution following Standard Operating Procedures
• Comply with relevant Springer Nature policies, COPE guidelines and industry best practices
• Identify legal and reputational risk and liaise with internal legal and communications teams to mitigate these risks
• Manage a high-volume workload of concurrent cases to meet targets and Key Performance Indicators
• Keep meticulous records of cases up to date and contribute to reporting
• Contribute to training and mentoring, training materials, policy development, workflow improvements, presentations, workshops and projects, by maintaining a strong understanding of the evolving publication ethics landscape identifying new types of issues, and be action oriented by proactively addressing emergent needs

Research Integrity Specialist

• Contribute to the success of the BMC Series by supporting editorial handling of content in BMC Health Services Research and by driving the content development of these journals
• Develop a journal development strategy for BMC Health Services Research
• Work with colleagues across the Journals group to support subject-specific strategy development at Springer Nature
• Identify and commission reviews, collections and supplements
• Oversee the handling of the content published in BMC Health Services Research
• Investigate and resolve publishing or research ethics cases
• Build excellent communication and relationships with Editorial Board Members and authors
• Host regular Senior Board and Editorial Board Meetings
• Develop journal website content and features
• Attend conferences to promote the journals
• Contribute to the culture of the BMC editorial team

Associate or Senior Editor, BMC Health Services Research

• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
• Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
• Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
• Considered as the primary point of contact for the investigative site.
• High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
• Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies).
• Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
• Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
• May participate in global/local task forces and initiatives.
• Responsible for activities as assigned by manager.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
• Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
• Manages investigator payments as per executed contract obligations, as applicable.

Clinical Research Associate II

• Act as Parexel’s direct contact with assigned sites
• Assess and ensure overall integrity of study implementation and adherence to study protocol
• Build relationships with investigators and site staff
• Evaluate if on-site staff assignment is still accurate
• Apply working knowledge and judgment to identify potential data quality issues
• Monitor and maintain compliance with ICH-GCP and applicable regulations
• Perform site facilities assessments
• Ensure timely and accurate completion of project goals

Clinical Research Associate I/II

• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
• Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
• Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
• Customize site engagement strategy for assigned study (ies) under supervision.
• Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Clinical Research Associate I

• Drive study performance at the sites.
• Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents.
• Provide the required monitoring visit reports within required timelines.
• Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
• Contribute to the selection of potential sites and investigators.
• Train, support and advise Investigators and site staff in study related matters.
• Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations.
• Manage study supplies, drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Ensure data query resolution.
• Work with data management to ensure quality of the study data.
• Ensure accurate and timely reporting of Serious Adverse Events.
• Share relevant information on patient recruitment and study site progress within local Study Team.
• Update VCV and other systems with data from centers as per required timelines.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.

Research Analyst jobs in China

See all jobs on JobTailor

Research Integrity Specialist

Associate or Senior Editor, BMC Health Services Research

Clinical Research Associate II

Clinical Research Associate I/II

Clinical Research Associate I

Clinical Research Associate II – CART