Job Title : Global Study Coordinator
Company Name : Glaxo Smith Kline
Locations : Bangalore, India
Qualification and requirement :
Company Name : Glaxo Smith Kline
Locations : Bangalore, India
Qualification and requirement :
- University degree / Post-graduate degree in biological sciences Genetics, Biotechnology, microbiology etc.
- 3-4 years experience in clinical trials environment as clinical monitor or clinical research associate (with monitoring experience).
- Good knowledge of GCP and clinical trials processes
- Basic knowledge of IT tool
- Excellent English communication skills.
Responsibility :
- The role will focus on evaluation of safety and effectiveness of the drug. Includes Phases I to IV. Some roles might demand patient interaction while others are limited to consulting, benchwork and analysis. The primary responsibilities include the design, planning, organization, analysis and evaluation of studies during clinical trials.
- Work under supervision of a Global Study Manager (GSM) and participate to the study coordination. (S)He learns the GSM function (on the job training), attend trainings, put into practice information given during trainings, GSM meetings, SOP session… and apply them correctly on the study he/she gives support:
- Acquire good knowledge of ICH-GCP and SOPs, of specific GSK Bio tools for Data collection and management, of archiving processes, etc
- Acquire monitoring experience via co-monitoring visits with GSMs, participate (according to acquired skills) to pre-study, initiation/close-out visits, audit according to growing experience, gain autonomy for monitoring visits. Prepare the monitoring visit report under supervision. Depending on level of experience- perform independently monitoring visits.
- Have contacts in framework of specific tasks/responsibilities with LOC staff monitors and if applicable with investigators. Take over, according to experience level, the contact point role of the GSM for single/multiple country study.
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