Custodian - Lucknow, Uttar Pradesh, India - MEDICLIN CLINICAL SERVICES PVT LTD

MEDICLIN CLINICAL SERVICES PVT LTD

Verified Company

Lucknow, Uttar Pradesh, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Responsible for preparation for relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.

Training of relevant SOPs to other staff of department.
Responsible for volunteer recruitment as per requirement of the study within given time limit in consultation with Principal Investigator / Medical Officer/ Head-CPU
Coordinating with the volunteers for screening related activities like contacting the volunteers for screening dates, screening reports related information etc.
Obtaining freewill and written informed consent from the volunteers for registration process and for distribution of screening consent in coordination with Principal Investigator / Co-Investigator / Medical Officer.
Registration of volunteers as per the current SOPs.
Responsible for operation and maintenance of volunteer's data base.
Providing inputs to improve efficiency of screening process.
Ensuring that the volunteers are well informed about the study requirements, restrictions and study schedule.
Ensuring compliance of the volunteers for study restrictions as per protocol.
Spot audit and system audit response preparation.
Ensuring volunteers comfort during conduct of the clinical study.
Ensuring that the volunteer maintain discipline during their stay in the facility.
Ensure admission and discharge of volunteers at clinical facility during the conduct of a clinical study.
Arrangement and distribution of compensation to volunteers.
Assist Principal Investigator/ Head-CPU during audit process (QA audit, any regulatory/Sponsor audit etc) at all time.
Any other activity delegated by Head-CPU/Principal Investigator/Designee