Clinical Research Coordinator
希奥莱姆医药科技咨询(上海)有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-08-18
- 工作地点:重庆
- 招聘人数:若干
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:临床协调员
职位描述
To perform other reasonable activities as instructed by his/her direct line manager(s)
? To travel domestically and internationally as required to carry out the job responsibilities as noted in this section.
? Complete required foundation training within required timeline, and complete the evaluation and assessment;
? Assist in source document collection and maintenance (including patient charts, reports, inform consent forms etc.);
? Assist in site file document collection and maintenance;
? Clinical data entry into CRF and query resolution (non?medically related);
? Assist in subject visit management including subject screening, enrollment, treatment, follow up and subject education;
? Author and finalize site visit reports(SVR) , if applicable upload SVRs electronically to the system;
? Assist in drug or device management, including drug/device request, receipt, accountability, dispensing and return activities, also
including study drug storage and temperature record;
? Assist investigators with study sample management, including subject specimen collection, processing, labeling &packing, shipment,
accountability and tracking, sample storage and temperature record;
? Assist investigators in study supplies management, including request, receipt, maintenance, counting and tracking;
? Attend the project CRC meeting and study specific training;
? Assist in audit or inspection preparation and arrangement at investigator site (if applicable);
? Assist in negotiating clinical trial agreement(s) (CTA) and supplement(s);
? Assist in processing site payment, subject reimbursement and invoice collection;
? Assist in Ethic Committee document (IECs) submission and follow?up of notification/approval;
? Assist in other site activities (e.g. site feasibility, site selection, site initiation, site close?out visit);
? Assist in communication with study related partners (including CRA, vendors and sponsor), investigator and other institution/hospital departments.
? To travel domestically and internationally as required to carry out the job responsibilities as noted in this section.
? Complete required foundation training within required timeline, and complete the evaluation and assessment;
? Assist in source document collection and maintenance (including patient charts, reports, inform consent forms etc.);
? Assist in site file document collection and maintenance;
? Clinical data entry into CRF and query resolution (non?medically related);
? Assist in subject visit management including subject screening, enrollment, treatment, follow up and subject education;
? Author and finalize site visit reports(SVR) , if applicable upload SVRs electronically to the system;
? Assist in drug or device management, including drug/device request, receipt, accountability, dispensing and return activities, also
including study drug storage and temperature record;
? Assist investigators with study sample management, including subject specimen collection, processing, labeling &packing, shipment,
accountability and tracking, sample storage and temperature record;
? Assist investigators in study supplies management, including request, receipt, maintenance, counting and tracking;
? Attend the project CRC meeting and study specific training;
? Assist in audit or inspection preparation and arrangement at investigator site (if applicable);
? Assist in negotiating clinical trial agreement(s) (CTA) and supplement(s);
? Assist in processing site payment, subject reimbursement and invoice collection;
? Assist in Ethic Committee document (IECs) submission and follow?up of notification/approval;
? Assist in other site activities (e.g. site feasibility, site selection, site initiation, site close?out visit);
? Assist in communication with study related partners (including CRA, vendors and sponsor), investigator and other institution/hospital departments.
公司介绍
Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics.
So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:
? Project Management
? Clinical Monitoring*
? Clinical Data Management*
? Regulatory Affairs*
? Clinical Quality Assurance
? Safety Surveillance/Pharmacovigilance*
? Biometrics*
? Clinical Writing
? Investigator Agreements
? Medical Affairs
? Patient Recruitment
The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.
Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.
So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:
? Project Management
? Clinical Monitoring*
? Clinical Data Management*
? Regulatory Affairs*
? Clinical Quality Assurance
? Safety Surveillance/Pharmacovigilance*
? Biometrics*
? Clinical Writing
? Investigator Agreements
? Medical Affairs
? Patient Recruitment
The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.
Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.