Job Title: Associate Clinical Manager
Experience Required: 0 – 4 years
Job Type: Full Time
Location: Shivalik
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 for preparation of Protocol.
Assist with the development of the Informed Consent Form (ICF) and Case Report Form (CRF).
2. Ethics Submission
Work with the investigator to submit study-related documents and updates to the Independent Ethics Committee.
3. Study Management
Assist investigator in study schedule planning.
Coordinate with the screening team for subject recruitment and screening.
Ensure volunteers are eligible and fit for participation per study protocol.
Conduct ICF presentations for potential study participants.
Perform clinical examinations and monitor vitals throughout the study duration.
Safeguard subject safety and handle/report adverse events, reactions, and clinical emergencies.
Make clinical decisions in the absence of the investigator and seek their input as necessary.
Supervise nursing staff in maintaining emergency medicine and Special Care Room preparedness.
Offer medical assistance to both study subjects and employees.
Oversee and ensure that clinical studies are compliant with the approved protocol, ICH-GCP guidelines, and internal SOPs.
Coordinate subject admission, discharge, meal distribution, dosing activities, and monitoring for compliance.
Generate and maintain all essential documents for each study.
4. Report Preparation
Document protocol and SOP deviations during clinical assessments and vital checks.
Collaborate with the investigator to include these in the final study report.
5. Feasibility Assessment
Support feasibility analysis of new molecules by working with clinical research teams.
6. Other Duties
Perform any additional tasks as directed 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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