Medical Doctor - Lucknow, India - MEDICLIN CLINICAL SERVICES PVT LTD

MEDICLIN CLINICAL SERVICES PVT LTD

Verified Company

Lucknow, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

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

Training of relevant SOPs to all staff of the department.
Providing study related information and assist in obtaining written informed consent from volunteers for their participation in the clinical study.
Coordinate with various departments like clinical laboratory (Contract Service), administration for proper functioning of screening process.
Assist Principal Investigator / Co
Investigator in preparation of protocols as per current technicalities with respect to ICH GCP guidelines and other regulatory requirements.
Preparation of case report form/study source record and informed consent document in consultation of Principal Investigator / Co
Investigator.
Preparation and maintenance of clinical study Trial master file.
Assist Principal Investigator / Co
Investigator in conducting prestudy meeting to ensure that all personnel are updated about protocol and its requirements.
Ensure that the study is conducted in compliance with approved Protocols, relevant SOPs and applicable regulatory requirements.
To supervise/perform dose administration procedure.
Preparation of clinical study updates after completion of each study period.
To ensure review of study related documents before sending to QA department for audit.
Demonstrate leadership contribute to an atmosphere of teamwork and provide collaboration with external and internal clients.
Assist Principal Investigator / Co
Investigator in study related all internal and external communications. Prepare audit responses in consultation with Principal Investigator / Co
Investigator.
Assist monitor/ auditor during the conduct of clinical study.
Investigator / Head-CPU.
Assist Principal Investigator/ Co
Investigator/ Head-CPU during audit process (QA audit, any regulatory/Sponsor audit etc.) at all times.
Supervising drug verification (if required), drug dispensing, drug retrieval and disposable process.
Any other activity delegated by Head-CPU or designee.
Communication with EC, Submission of document to EC/Sponsor.
Implementation of safety management system requirements at work places along with maintenance of zero injury & fire incident.