Custodian
6 months ago
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 free-will 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
Pay: ₹8,000.00 - ₹9,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
**Education**:
- Higher Secondary(12th Pass) (preferred)
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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