Job Title: Clinical Manager
Experience Required: 0 – 2 years
Job Type: Full Time
Location: Mehsana
Department: Clinical Research Department (CRD)
Function: Clinical Research Physician
Functional Role:
Clinical Investigator / Clinical Research Physician
Reporting To:
[To be filled by organization]
Primary Responsibilities:
1. Protocol, ICF, and CRF Preparation
Coordinate with clinical research personnel to prepare study Protocols.
Assist in drafting the Informed Consent Form (ICF) and Case Report Form (CRF).
2. Ethics Submission
Support investigators in submitting study-related documents (e.g., updates, protocols) to the Independent Ethics Committee.
3. Study Coordination
Collaborate with investigators to plan study schedules.
Coordinate with the screening team for subject recruitment and screening.
Ensure volunteers attending ICF presentations meet protocol requirements.
Conduct ICF presentations and assist during subject enrollment.
Perform clinical examinations and monitor vital signs throughout the study.
Ensure subject safety and report adverse events, drug reactions, or clinical emergencies.
Make clinical decisions in the absence of the investigator and consult with them as needed.
Guide nursing staff on emergency medicine management and Special Care Room protocols.
Provide medical assistance to study subjects and employees.
Ensure compliance with the protocol, ICH-GCP guidelines, and in-house SOPs.
Coordinate clinical staff during admission, discharge, dosing, and subject monitoring.
Maintain and generate study-essential documents.
4. Report Preparation
Identify and list protocol/SOP deviations during clinical exams or vitals.
Collaborate with the investigator to incorporate findings in the final report.
5. Feasibility Assessment
Coordinate with research personnel to assess feasibility of various molecules for study.
6. Other Duties
Carry out additional tasks as assigned by the reporting authority.
Prepared By (Reporting Manager):
Name: [To be filled]
Designation: [To be filled]
Signature: ____________
Date: ____________
Reviewed By (Department Head):
Name: [To be filled]
Designation: [To be filled]
Signature: ____________
Date: ____________
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