Clinic Study Administrator - 2828
Location: Navi Mumbai, IN, 400706
Job Description :
- Overseeing the smooth running of BA/BE studies.Collecting, compiling, completing and reviewing data obtained from research.
- Informing participants about study during ICF process.Get involved in the Investigational product administration process.
- To act as a custodian and monitoring of research participants to ensure adherence to study rules.Adhering to research regulatory standards and in-house SOPs.
- Adhering to ethical standards like ICH-GCP and GLP.Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.
- Co-ordination with pathology laboratory regarding screening, post study and follow up sample analysis.
- Participating in subject enrollment efforts for new BA/BE studies.
- Ensuring that the necessary supplies and equipment for a study are available before initiation of study.
- Engaging with study staff for timely completion of study documentation to meet stringent timelines of project submission.Collects data as required by the
- protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.Completes study documentation and maintains study files in accordance with requirements as per in house SOPs and procedures
- including, but not limited to, consent forms, source documentation, case report forms and investigational material accountability forms (if required).
- Engaging with subjects and understanding their concerns.
Qualifications : 1-2 Yrs Exp B. Pharm, M. Pharm, M.Sc. (Clinical Research) or B.Sc