[MD&D] Clinical Research Specialist (Contractor)-1400011204W
Description
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
General Summary:
- Plans, coordinates, and executes research programs conducted by Medical Affairs.
- Performs project management, safety reporting, data coordination/management and reporting/communication of results.
Duties & Responsibilities:
- Assure the protection of the rights, safety and well being of human study subjects.
- Perform all clinical monitoring/ site management activities for assigned projects in accordance with SOP.
- To analyze and evaluate clinical data, to ensure investigator and site compliance with the study protocol, overall clinical objectives, MFDS regulations, ICH Guidelines, Good Clinical Practice (GCP).
- Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
- To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
- To make certain that the scientific integrity of the data collected is protected and verified.
- Assure that adverse events are correctly documented and reported.
- Review all case report forms and compare them to source documents.
- Maintain appropriate communication with internal and external parties.
Requirement
- CRA/CRC experiences are preferred
- Pharmaceutical and Medical Device Industry experiences are preferred
- Fluent in English
- Effective written and verbal communication skills
Qualifications
above
Primary Location:Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization: Johnson & Johnson Medical Korea (Ltd.) (7225)
Job Function: Medical Affairs
Description
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
General Summary:
- Plans, coordinates, and executes research programs conducted by Medical Affairs.
- Performs project management, safety reporting, data coordination/management and reporting/communication of results.
Duties & Responsibilities:
- Assure the protection of the rights, safety and well being of human study subjects.
- Perform all clinical monitoring/ site management activities for assigned projects in accordance with SOP.
- To analyze and evaluate clinical data, to ensure investigator and site compliance with the study protocol, overall clinical objectives, MFDS regulations, ICH Guidelines, Good Clinical Practice (GCP).
- Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
- To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
- To make certain that the scientific integrity of the data collected is protected and verified.
- Assure that adverse events are correctly documented and reported.
- Review all case report forms and compare them to source documents.
- Maintain appropriate communication with internal and external parties.
Requirement
- CRA/CRC experiences are preferred
- Pharmaceutical and Medical Device Industry experiences are preferred
- Fluent in English
- Effective written and verbal communication skills
Qualifications
above
Primary Location:Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization: Johnson & Johnson Medical Korea (Ltd.) (7225)
Job Function: Medical Affairs