Medical Writing Protocol
Lotus Labs Private limited
2 - 4 yrs
Bengaluru/Bangalore
Job Description
- Roles and responsibility:
Preparation of the CRF, follow up for inputs and finalization.
Preparation of draft protocol based on the Data collection form received from the (Group/ Team Leader Medical Writing- Protocol) GL MW-P/ TL- MW-P and the literature review done for the study molecule.
Discussing, obtaining and incorporating inputs from the Sponsor, Pharmacokinetic, analytical, statistical, Quality assurance dept, Principal Investigator, Clinical investigator and Medical advisor.
Organizing and co-ordinating protocol review meets when ever required by Principal Investigator.
Self Quality check (QC) for the draft as per the template/sponsor specific template of protocol before sending the initial draft to internal department inputs.
- Detailed description of MAIN tasks and responsibility :
Hard copy of the Final protocol, ICDs, CRF and other related documents compiled together as a Original copy.
Submission of protocol, appendices and related documents (soft copy and Hard copy) to Ethics committee for the study approval.
Making version change, amendment for protocol and related documents and submitting the same to Ethics Committee for approval as and when required.
A PDF copy or read only copy (password protected) of the final signed protocol is circulated to the CRC, clinical QA, clinical report writing group, analytical QA and Biometrics department if all phases of study is conducted in Lotus. If only clinical phase of the study is conducted in Lotus, the final protocol is circulated to CRC, clinical QA and report writing group.
Maintenance of protocol distribution log book to Ethics committee
Hard copy of the original protocol with original signatures from all the signatories of Lotus and original signed copy or scanned copy of the sponsor declaration will be spiral bound together and sent to CRC for filing the original in ISF during the study period.
Review the final hard copies of protocol with applicable appendices and all other study related documents like ICDs, CRF, Food Menu, Investigators Undertaking to be sent EC for accuracy and compilation before submission.
Finalization of the protocol from initiation till dispatch to sponsor, if there is any sponsor specific procedure required to be followed, then the same will be followed
Sending final protocol, ICD, Investigator undertaking with EC approval to Regulatory team for DCG(I) submission.
Finalizing the protocol on concord with sponsor.
Preparation of protocol related documents, like the study flow chart, Study design and other study specific documents as specified in the (EC) Ethics Committee covering letter.
Preparation of the ICDs, co-ordination to make Food menu, ICD in regional and back translated ICD and related documents..
Maintenance of protocol distribution log book to Ethics committee
To carryout other responsibilities as and when assigned by GL MW-P/ TL- MW-P / Management
- Company Profile:
Lotus Labs Private limited
http://www.lotuslabs.com
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