Jyotsna Bittu

Work in compliance with standard protocol, regulatory requirement and ICH GCP obligations in assigned aspects of clinical site monitoring

 Aid Principal Investigator or Sub-Investigator during AV and oral Consent process and give preliminary assistance for the voluntary consent.

Maintain the source document and Filling Case Report Forms and Electronic Data Capture.

 Providing Data clarification for the queries raised during the monitoring visit.

 Co-ordinate with the PI for Safety follow up of study participants, identification and reporting of

AE.

 Ethics committee notifications preparation and submission to Institutional Ethics Committee

(IEC).

 Experienced monitoring visits with CRA.

 Experienced in Sponsor audit, QA audit.

 Maintaining study specific logs (Pre-screening log, Patient identification log, Patient Screening and enrolment log, visit tracking log, Temperature log, Biological sample log, Protocol deviation log, AE (Adverse Event) log, Concomitant or prior medication log, IP Accountability log).

Maintain the source document and Filling Case Report Forms and Electronic Data Capture.

 Providing Data clarification for the queries raised during the monitoring visit.

 Co-ordinate with the PI for Safety follow up of study participants, identification and reporting of

AE.

 Ethics committee notifications preparation and submission to Institutional Ethics Committee

(IEC).

 Experienced monitoring visits with CRA.

 Experienced in Sponsor audit, QA audit.

 Maintaining study specific logs (Pre-screening log, Patient identification log, Patient Screening and enrolment log, visit tracking log, Temperature log, Biological sample log, Protocol deviation log, AE (Adverse Event) log, Concomitant or prior medication log, IP Accountability log).

Pharm-D

(DOCTOR OF PHARMACY)

JNTUK,Kakinada,A.P

88%

Intermediate

HSB

94.1%

SSC

SSC

9.2(CGP)