【招聘CPA/CRC】上海切尔西医药科技咨询有限公司

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

lawsoenaingUID: 3430143

谢谢分享

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

ChelseacrUID: 3406663

我司是从事新药临床研究的，强项是肿瘤，主要做三期临床。目前与五百强制药公司合作，主要做的是国际多中心的GLOBAL项目，目前在上海有CPA和CRC的工作机会。诚聘各位海外留学归国优秀人才，专业要求：临床医学、护理学、基础医学、药学、制药工程等相关医药学专业。下面是CRC/CPA与CRA的JD，该职位的发展过程是CRC/CPA-CRA-Senior CRA-项目经理-项目总监。
有兴趣的同学可以做具体了解，应聘简历请投至公司HR邮箱：hr@chelseacr.com

Clinical Project Assistant（项目助理）

To provide administrative support of the set-up, monitoring and reporting of clinical trials in conformity with GCP and company SOP in order to facilitate to a high extent the execution of the research projects;

- Perform all duties/responsibilities in a professional manner;
- Handle/record confidential corporate documents;
- Screen incoming calls and all correspondence and respond independently when possible;
- Maintain various tracking logs;
- Maintains/updates board manuals and resource materials;
- Make hotel reservation and book air tickets;
- Other duties may be assigned.


Requirements:

- Master or above Degree;
- Excellent professional, organizational and interpersonal skills;
- Excellent oral and written communication skills;
- Excellent English both in written and verbal (Band 6 is a MUST);
- Ability to work independently, self-starter, work under pressure, accept responsibilities and learn new tasks;
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Prior pharmaceutical or medical experience is desirable;
- Have some basic knowledge about clinical research.
  

Clinical Research Coordinator（临床研究协调员）  
工作地点：三甲医院

Responsibility:
- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;
- To participate in the recruitment and screening of research patients;
- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;
- To collect, prepare and submit of regulatory documents as per required by the site EC;
- To attend site initiation meeting;
- To prepare the documents for study monitor site visits;
- To assist investigator in obtaining proper written consent from each study participant according to the requirement;
- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;
- To complete and correct case report forms ensuring accuracy of all records connected with each research patients;
- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;
- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;
- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events;
- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;
- To update the TMFs and ensure the accuracy and completeness of TMFs;
- To perform other duties as required.


Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Detailed orientated;
- Organizational skills;
- Ability to multi-task;
- Can work under pressure;
- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

Your may also find our advertisement in www.51job.com for the Clinical Research Coordinator position.


Clinical Research Associate（临床研究监察员）
- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the clients and project team.

Requirements:
- Bachelor or above Degree in medicine, pharmacy science or nursing;
- More than 1 year clinical monitoring experience in global oncology studies according to SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

duijinxiaoziUID: 2585955

支持！