Sub-Investigator

Novumgen; Vadodara; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Novumgen is seeking a Sub-Investigator in Vadodara, India, to assist the Principal Investigator in conducting clinical studies per approved protocols and SOPs. The role involves medical assessments, eligibility reviews, and coordinating safety monitoring and follow-up while maintaining strict confidentiality and documentation integrity.

The candidate should have MBBS or MD and 2–3 years of experience in handling clinical study activities, with adherence to ICH-GCP and regulatory requirements.

Qualifications

• 2-3 years of experience in handling clinical study activities.
• MBBS/MD degree from a recognized medical college.

Responsibilities

• Support the Principal Investigator in the conduct of clinical studies in accordance with the approved protocol, amendments, and applicable SOPs.
• Perform study-related medical activities delegated by the PI and ensure activities are performed within the individual's qualifications, training, experience, and medical scope of practice.
• Review participant eligibility and relevant medical information as delegated by the PI.
• Conduct or support medical assessments, physical examinations, and other protocol-required clinical procedures.
• Monitor participants for clinical signs, symptoms, adverse events, and other safety concerns; inform the PI of significant findings.
• Ensure appropriate medical evaluation, management, and follow-up of participants, as required.
• Ensure appropriate medical intervention and referral where required.
• Support emergency medical management and escalation per protocol and site procedures.
• Maintain participant confidentiality and protect personal and medical information.
• Support the PI in the informed consent process and ensure informed consent is obtained before procedures.
• Provide participants with information regarding procedures, risks, benefits, alternatives, and requirements within the consent process.
• Ensure accurate, complete, contemporaneous, and traceable documentation of delegated activities.
• Ensure consistency between source documents and CRFs/eCRFs for delegated information.
• Review and respond to data queries within defined timelines; ensure corrections follow Good Documentation Practice and data integrity.
• Ensure no study-specific procedure is performed outside the protocol unless necessary to eliminate an immediate hazard.
• Participate in protocol and study-specific training before performing delegated activities.
• Support review and interpretation of laboratory and other clinically relevant results, where applicable.
• Support appropriate administration/use, monitoring, and accountability of investigational products as delegated.
• Support preparation and submission of safety reports to Sponsor, Ethics Committee and regulatory authorities, as applicable.
• Maintain compliance with regulatory requirements including ICH-GCP, NDCTR 2019, CDSCO requirements, and institutional requirements.
• Support PI during sponsor monitoring, audits, and regulatory inspections.

Education

MBBS/MD

Job description

Job Description

Position Title- Sub-Investigator

Department- Clinical Affairs

Experience Requirement:

2-3 years of experience in handling clinical study activities.

Qualification Requirement:

MBBS/MD.

Profile Requirements:

1. Support the Principal Investigator in the conduct of clinical studies in accordance with the approved protocol, amendments, and applicable SOPs.
2. Perform study-related medical activities delegated by the PI and Ensure that delegated activities are performed only within the individual's qualifications, training, experience, and medical scope of practice.
3. Review participant eligibility and relevant medical information as delegated by the PI.
4. Conduct or support medical assessments, physical examinations, and other protocol-required clinical procedures.
5. Monitor participants for clinical signs, symptoms, adverse events, and other safety concerns. Promptly inform the PI of significant medical findings, adverse events, protocol deviations, and other safety concerns.
6. Ensure appropriate medical evaluation, management, and follow-up of participants, as required.
7. Ensure appropriate medical intervention and referral where required.
8. Support emergency medical management and ensure appropriate escalation in accordance with the study protocol and site procedures.
9. Maintain participant confidentiality and protect personal and medical information.
10. Support the PI in the informed consent process and Ensure that informed consent is obtained before performing study-specific procedures.
11. Provide participants with adequate information regarding study procedures, risks, benefits, alternatives, and applicable requirements within the scope of the approved consent process.
12. Ensure accurate, complete, contemporaneous, and traceable documentation of delegated activities.
13. Ensure consistency between source documents and CRFs/eCRFs for information under the Sub-Investigator's responsibility.
14. Review and respond to data queries within defined timelines. Ensure that corrections to records are made in accordance with Good Documentation Practice and data integrity principles.
15. Ensure that no study-specific procedure is performed outside the approved protocol unless necessary to eliminate an immediate hazard to a participant
16. Participate in protocol and study-specific training before performing delegated study activities.
17. Support review and interpretation of laboratory and other clinically relevant investigation results, where applicable.
18. Support appropriate administration/use, monitoring, and accountability of investigational products as delegated and applicable to the study.
19. Support preparation and submission of safety reports to the Sponsor, Ethics Committee and regulatory authorities, as applicable and as delegated.
20. Maintain compliance with applicable regulatory requirements, including ICH-GCP, NDCTR 2019, CDSCO requirements, and applicable institutional requirements.
21. Support the PI during sponsor monitoring, audits, and regulatory inspections.