Clinical Research Coordinator
Lotus Labs Private limited
0 - 3 yrs
Bengaluru/Bangalore
Job Description
- Roles and responsibility:
Compilation of all documents for Investigator Site File (ISF).
Coordinating with the Clinical Investigator and arranging for all the material required for the smooth conduct of the study.
Coordinating for conducting study specific training.
Preparing and sending study updates for each period of the study to the sponsor.
Detailed description of MAIN tasks and responsibility:
Quality check of all the documents generated for a study (Dosing labels, vacutainer labels etc.)
Review of documents pertaining to investigational product and co-ordinate with project manager regarding the same.
Filled duty allotment form given for Clinical Investigators review and distributed.
Coordinating for conducting study specific training.
Quality control checks during the study: Informed consent process, Check-in, pre-dose and dosing process, blood sampling and processing activities.
Retaining of unused vacutainers and vials of the study till disposal or archival.
After every ambulatory draw details regarding absentees and late draws to be complied and submitted to CI/PI for review.
Compilation of data regarding missing samples, withdrawn subjects and adverse events.
Obtain authorization prior to dispatch of the details of the missing samples, withdrawn subjects and adverse events.
Preparing and sending of study updates for each period of the study to the sponsor.
Quality check of the documents generated, compilation, correction, photocopying and submission to Quality Assurance.
After getting the observations back from QA relevant correction to be done accordingly and cleared.
Study completion reports are submitted to the Ethics Committee.
Study report and relevant documents are dispatched to the sponsor.
The study data and ISF are archived within 30 days of issue of report to the sponsor.
Report to respective Head-Clinical Unit on all activities.
Company Profile:
Lotus Labs Private limited
http://www.lotuslabs.com
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