RWE Clinical Research Associate-Cerner

2 weeks ago


Shanghai, China Oracle Remote Work Freelance Full time

Job 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 qualifications Recruit and select investigators IRB and HGRAC preparation, submission and closing; contract preparation and negotiation with research organizations and vendors. Monitor investigator performance and adherence to protocols, followed all GCP and GPP procedures and internal SOP  Data management, to ensure the enrollment process and the quality of data input Site initiation and monitoring Prepare progress report upon requests and related materials for client meetings Manage ongoing studies and maintain good relationship with clients

Qualifications of the ideal candidate:

Bachelor’s degree or above in related discipline, preferably in life science or health-related majors More than 2 years experiences in CRA Understanding of the Health system policy & management in key global markets, pharmaceutical industry; competitive environment and product development process  Must work well in a collaborative research environment as well as can work independently with limited supervision  Enjoy working as part of a team in a fast-paced environment. Excellent time management skills and ability to multi-task and prioritize work. Good communication, negotiation and problem-solving skills Solid oral and written communication skills in both Chinese and English with ability to describe complex scientific data to a non-technical audience are a must.

Job 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 qualifications Recruit and select investigators IRB and HGRAC preparation, submission and closing; contract preparation and negotiation with research organizations and vendors. Monitor investigator performance and adherence to protocols, followed all GCP and GPP procedures and internal SOP  Data management, to ensure the enrollment process and the quality of data input Site initiation and monitoring Prepare progress report upon requests and related materials for client meetings Manage ongoing studies and maintain good relationship with clients

Qualifications of the ideal candidate:

Bachelor’s degree or above in related discipline, preferably in life science or health-related majors More than 2 years experiences in CRA Understanding of the Health system policy & management in key global markets, pharmaceutical industry; competitive environment and product development process  Must work well in a collaborative research environment as well as can work independently with limited supervision  Enjoy working as part of a team in a fast-paced environment. Excellent time management skills and ability to multi-task and prioritize work. Good communication, negotiation and problem-solving skills Solid oral and written communication skills in both Chinese and English with ability to describe complex scientific data to a non-technical audience are a must.

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