Clinical Investigator / Principal Investigator (MBBS/MD Doctor)

About the Role:

We are looking for a qualified and experienced Clinical Investigator to lead and oversee clinical trial activities at our Mehsana research site. The ideal candidate will be responsible for ensuring patient safety, protocol compliance, regulatory adherence, and successful execution of clinical studies.

Key Responsibilities:

• Act as Principal Investigator/Sub-Investigator for assigned clinical studies.
• Conduct subject screening, enrollment, and eligibility assessments as per study protocol.
• Obtain and document informed consent from study participants.
• Ensure clinical trials are conducted in compliance with ICH-GCP, SOPs, and applicable regulatory requirements.
• Perform medical evaluations and clinical assessments of study subjects.
• Review and evaluate adverse events (AEs), serious adverse events (SAEs), and ensure timely reporting.
• Maintain accurate and complete source documentation and study records.
• Collaborate with sponsors, CRO representatives, ethics committees, and regulatory authorities.
• Ensure protocol adherence and data integrity throughout the study.
• Participate in site initiation, monitoring, audits, and inspections.
• Provide medical oversight and support to study coordinators and site staff.
• Maintain confidentiality of study-related information and participant data.

Desired Candidate Profile:

• MBBS with valid medical registration.
• 2+ years of experience in clinical research or clinical trial management.
• Sound knowledge of ICH-GCP, Schedule Y, and clinical research regulations.
• Experience in patient recruitment and clinical trial conduct will be preferred.
• Strong documentation and communication skills.
• Ability to work independently and manage multiple studies simultaneously.

Preferred Skills:

• Clinical Trial Management
• Medical Review
• Regulatory Compliance
• GCP Certification
• Pharmacovigilance Awareness
• Patient Safety Management
• Protocol Review
• Electronic Data Capture (EDC)