M Pharma B Pharma and Msc

Responsible for preparation for relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.
- Responsible for receiving, complete accountability and storage of Investigational Products (IPs) as per SOPs and regulatory guideline.
- Responsible for proper unit dose dispensing as per randomization schedule generated during conduct of the studies.
- Responsible for retrieving of dispensed IPs from pharmacy for dose administration on dosing day.
- Responsible for prepare responses of sponsor queries with respect to IPs.
- Ensure that the study is conducted in compliance with approved protocols, relevant SOPs and applicable regulatory requirements.
- Responsible for ensuring adequate IPs retention studies as per the SOPs and regulatory requirement.
- Responsible for disposal of IPs as per SOPs and regulatory requirement.
- Communicate to sponsor in case of any discrepancy related to IPs during receipt of investigational product.
- Responsible for operation and maintenance of pharmacy and stability chamber as per SOPs.
- 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

**Salary**: ₹12,000.00 - ₹15,000.00 per month

**Benefits**:

- Health insurance
- Leave encashment
- Provident Fund

Schedule:

- Morning shift

Ability to commute/relocate:

- Lucknow, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- Nursing (preferred)
- one year (preferred)

**Language**:

- Thoda English (preferred)

License/Certification:

- Nursing License (preferred)

**Speak with the employer**
+91 9935924340
- Health insurance