Preparation of Study documents
Co-ordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation
To prepare documents for complex studies (e.g. phase I, steady state, injections, inhalations, patch, gel, complex design (like biosimilar study, food effect, dose proportionality, drug-drug interaction, two-stage design) etc.)
To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable.
To Prepare of the CRFs and other working documents, if applicable.
To prepare documents for submission to the regulatory.
Incorporate the protocol comments received from Investigator, QC,
QA, BR and Sponsor before finalization of the same.
Internal QC of study documents
Literature Search
To prepare departmental SOP and review cross-functional SOPs for their impact, preparation of project based check-list and ensure compliance by team.
Effectively plan, prioritize,
and manage multiple protocols to ensure timely completion within agreed timelines.
Feasibility of the study proposal
To assist Project Manager for feasibility assessment of study proposal.
Literature survey for PK & Safety study
IEC Communication
Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application.
To prepare documents for submission to the Ethics Committee (EC).
Any other task given by reporting authority.
MIS
Help to maintain the Audit tracker.
Team development & Team management
Support and help resolve inter and intra-departmental issues for achieving organizational objectives.
Responsible to manager departmental work in the absence of the reporting manager.
Responsible for team development by mentoring and training.
Any other task assigned by reporting authority.
Involvement in training to current joiners.
To review of the study documents prepared by the team.