How you’ll spend your day
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.
Your experience and qualifications
B. Pharm, M. Pharm or M.Sc. (Clinical Research).
At least 2-8 years of experience as a Clinical Research Coordinator in reputed BA/BE center.
