Medical Doctor
2 weeks ago
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 pre-study 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.
**Job Type**: Part-time
Expected hours: No less than 30 per week
Schedule:
- Day shift
- Night shift
Supplemental pay types:
- Shift allowance
**Education**:
- Bachelor's (preferred)
**Experience**:
- Physician: 1 year (preferred)
- total work: 1 year (preferred)
Ability to Commute:
- Lucknow, Uttar Pradesh (required)
Ability to Relocate:
- Lucknow, Uttar Pradesh: Relocate before starting work (required)
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