R&G PharmaStudies Co., Ltd.

Job title：

CRC

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Location：

beijing

Demand Number：

5 人

Welfare：

Date：

2009-10-28

Requirements：

1. Assisting investigators completing clinical trials in accordance with FDA/SFDA regulations, ICH-GCP guidelines, and protocol.

2. Subjects recruitment, screening, follow-up.

3. Documents collection, filing and management.

Required Skills & Qualifications:

1. Junior college or above degree in nursing or clinical or related fields.

2. Fluency English on both reading & written, good listening & verbal communication skills.

3. Prefer to have clinical experience.

4. Strong ability to work independently, team work spirit.

Job title：

Senior CRA

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Location：

beijing

Demand Number：

1 人

Welfare：

Date：

2009-10-28

Requirements：

1. Making sure that clinical trials are conducted in accordance with FDA/SFDA regulations, ICH-GCP guidelines, and protocol.

2. Ensuring that the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

3. Ensuring the integrity of the data submitted on CRFs or other data collection tools by careful source document review.

Required Skills & Qualifications:

1. Medical background, minimum bachelor’s degree, a minimum of 1 years work experience.

2. Familiar with regulatory of Provisions for Drug Registration, drug clinical trial and GCP.

3. Having skillful computer application ability

4. Good spoken and written English

5. The good interpersonal relationship, communication, presentation skills, verbal expression ability

6. Frequent travel for business will be required.

Job title：

CRA

Apply

Location：

beijing

Demand Number：

5 人

Welfare：

Date：

2009-10-28

Requirements：

1. Partnering with the medical monitor, clinical staff, and other departments, ensure clinical trials conducted in accordance with Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable national regulations (SFDA)

2. Draft and participate in the development of relevant documents for Phase 1 through 4 studies including protocols, informed consents, CRFs, monitoring plans, data management plans, abstracts, presentations, and manuscripts and clinical study reports.

3. Assist in the preparation and finalization of corporate SOPs. Assist in the preparation of safety, interim and final study reports and resolving data discrepancies.

4. Perform site visits for data collections, source data verification, and review of regulatory documents/files.

5. Participate in evaluating study drug supply requirements and managing logistics. Interact and communicate effectively with investigators and sponsors

6. Requires minimal direction to determine methods and procedures on new assignments.

7. Travel up to 25%.

Required Skills & Qualifications:

Education Medical school education with BS certificate (or higher), Experience

One year of CRA working experience (or related clinical experience) with:

1. Understand the concepts of global clinical trial, ICH and SFDA guidelines, with basic knowledge of US FDA regulations,

2. Ability to read and understand protocols, study design, endpoints, subject selection criteria, AE and SAE reports

3. Basic statistic concept

4. Ability to conduct site selection, monitoring of pre-study, initiation, interim, clost-out

5. Good communication in English and Chinese: verbal, writing, and presentations, interpersonal and presentation skills

6. CRA job training record as a clinical research professional

7. Information search ability on websites and website design interests