Description

Role & responsibilities Preparation of Study documents: Coordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation Prepare Informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. Preparation of the CRFs and other working documents, if applicable. 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 2. Feasibility of the study proposal Assist PM for feasibility assessment of study proposal. Literature survey for PK & Safety study. 3. IEC Communication: Coordinate with Principal Investigator (PI) and/or Clinical Investigator (CI) for application Prepare documents for submission to the Ethics Committee (EC). 4. Dose administration activity as required. 5. Perform any other duties as assigned by Group Leader. Preferred candidate profile Ability to prioritize task, expertise work in a short span of time, established interpersonal and communication skills, quality documentation and accounting skills, excellent computer proficiency and expertise in searching information through web.

Role and Responsibilities

• Role & responsibilities Preparation of Study documents: Coordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation Prepare Informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. Preparation of the CRFs and other working documents, if applicable. 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 2. Feasibility of the study proposal Assist PM for feasibility assessment of study proposal. Literature survey for PK & Safety study. 3. IEC Communication: Coordinate with Principal Investigator (PI) and/or Clinical Investigator (CI) for application Prepare documents for submission to the Ethics Committee (EC). 4. Dose administration activity as required. 5. Perform any other duties as assigned by Group Leader. Preferred candidate profile Ability to prioritize task, expertise work in a short span of time, established interpersonal and communication skills, quality documentation and accounting skills, excellent computer proficiency and expertise in searching information through web.