Senior / Clinical Research Associate(Beijing/Shanghai/Guangzhou/Other Cities)
3 weeks ago
Job 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 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 with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Sr. Advisor-Clinical Research
2 weeks ago
Shanghai, China Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. JOB DESCRIPTION JOB TITLE: Clinical Research Scientist (CRS) * BUSINESS UNIT OR AREA: Exploratory Medicine & Pharmacology (EMP) LOCATION: Shanghai REPORTS TO: Director-Medical** SALARY CLASS PROGRESSION: R3 through R8 ...
-
Clinical Research Associate II
3 weeks ago
Shanghai, China Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Clinical Research Expert/Lead
3 weeks ago
Shanghai, China Roche Full timeThe Position Job Summary : 1. The person may actively participate on cross-functional project teams responsible for the clinical research activities to support Roche Diagnostic China registration of products developed by Roche Group globally, such as, clinical software, instrument platforms, assays, reagents, devices, instruments, systems and...
-
Shanghai, China Springer Nature Group Full timeAbout Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 175 years our brands and imprints have been a trusted source of knowledge to these...
-
Senior Advisor, Clinical Research
3 weeks ago
Shanghai, China Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Core Job Responsibilities The primary responsibility of the CRP is to provide medical expertise to clinical strategic planning and execution, all aspects of the local business, and to ultimately enhance the customers' experience in scientific interaction with...
-
Shanghai, China Springer Nature Group Full timeAbout Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 180 years our brands and imprints have been a trusted source of knowledge to these...
-
Associate or Senior Editor, Genome Biology
1 week ago
Shanghai, China Springer Nature Group Full timeAbout Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 175 years our brands and imprints have been a trusted source of knowledge to these...
-
Shanghai, China Springer Nature Group Full timeAbout Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 180 years our brands and imprints have been a trusted source of knowledge to these...
-
RWE Clinical Research Associate-Cerner
2 weeks ago
Shanghai, China Oracle Remote Work Freelance Full timeJob description: Work under Real-World Evidence team Management and implementation of either global or local non-interventional studies (or Phase IV clinical research) Project coordinator and key contact of communication between sponsor and investigator Conduct site feasibility check, and selection activities for verifying adequate...
-
Forum Research Associate
3 weeks ago
Shanghai, China Third Bridge Full timeJob Description Forum is a content product that helps investors make better investment decisions faster. We conduct in depth Interviews with senior executives and industry specialists to unearth critical insights and generate unfiltered transcripts. Our 100-strong industry aligned team covers over 2,500 public and private companies, applying datadriven...
-
Shanghai, Shanghai, China Amgen Full timeThe Manager of Observational Research within Amgen's Center for Observational Research will guide the observational research to support drug development and regulatory decision-making. The role will serve as a strong partner within China R&D teams, Amgen's global network of epidemiologists, and the external research community.The location of the role is open...
-
Shanghai, China Amgen Full timeThe Manager of Observational Research within Amgen’s Center for Observational Research will guide the observational research to support drug development and regulatory decision-making. The role will serve as a strong partner within China R&D teams, Amgen’s global network of epidemiologists, and the external research community. The location of the role...
-
Senior Scientist, Clinical Pharmacology
3 days ago
Shanghai, China Johnson & Johnson Full timeObjective of Position The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply clinical pharmacology knowledge, including design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/ pharmacodynamics analyses and...
-
Senior Scientist, Clinical Pharmacology
3 days ago
Shanghai, Shanghai, China Johnson & Johnson Full timeObjective of Position The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply clinical pharmacology knowledge, including design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/ pharmacodynamics analyses and...
-
Shanghai, China NYU Shanghai Full timePosition Summary The Institutional Research Analyst assists in identifying, collecting, developing, modeling, analyzing, and communicating institutional data and other information for internal and external uses, by the instructions of Senior Manager of Institutional Research and Data Management. This role will also participate in institutional...
-
Faculty Services Associate, Faculty Affairs
3 weeks ago
Shanghai, China NYU Shanghai Full timePosition Summary Faculty Services Associates are key members of the Faculty Services Center, affiliated to the Office of Faculty Affairs. Office of Faculty Affairs oversees a variety of administrative support to academic areas/programs and serves as the resource center to individual faculty members through their whole lifecycle in the university, from...
-
Associate Director of Event Sales
3 weeks ago
Shanghai, China Hyatt Corporation Full timeAssociate Director of Event Sales - Alila Shanghai Alila Alila Shanghai CN - 31 - ShanghaiSalesDepartment Head/ManagerFull-timeReq ID: SHA003514 Summary You will be responsible for the efficient running of the department in line with Hyatt Hotels Corporation's Strategic Priorities, whilst meeting employee, guest and owner expectations To assist in...
-
Oncology Medical Lead/Clinical Scientist
2 weeks ago
Shanghai, China Roche Full timeThe Position The medical lead or principle/senior clinical scientist at the Early Development (ED) department of the China Innovation Center of Roche (CICoR) is responsible for providing medical/clinical expertise in the early clinical development strategy of a CICoR governed global program, driving clinical study design, progress, clinical data review...
-
Senior Applied Scientist, AWS Shanghai AI Lab
3 weeks ago
Shanghai, China Amazon Information Service (Beijing) Co., Ltd. (Shanghai Branch) Full timeDESCRIPTIONThe AWS Shanghai AI Lab is looking for a passionate, talented, and inventive staff in all AI domains with a strong machine learning background as a Senior Applied Scientist. Founded in 2018, the Shanghai Lab has been an innovation center of for long-term research projects across domains as machine learning, computer vision, natural language...
-
Director, Clinical Research Physician
3 weeks ago
Shanghai, China Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. This job is under LCDDMAC (Lilly China Drug Development and Medical Affair Center) focused on Autoimmune, a prospective critical therapeutic area of Lilly China. Lilly China is developing and entering this area with innovative medicine and strong pipeline in...
