Clinical Research Coordinator

2 hours ago

Lucknow Uttar Pradesh, India MEDICLIN CLINICAL SERVICES PVT LTD Full time

Key Responsibilities
- 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.

Pay: Up to ₹15,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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