M Pharma B Pharma and Msc

3 days ago

Lucknow, India MEDICLIN CLINICAL SERVICES PVT LTD Full time

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

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