Clinical Research Executive (Entry Level)

Job Description – Clinical Research Executive (Entry Level)

Position Overview

The Clinical Research Executive will be responsible for coordinating, monitoring, and managing clinical research studies in compliance with ICH-GCP, regulatory guidelines, and company SOPs. The role involves supporting protocol development, site management, documentation, and regulatory submissions for clinical trials of drugs, biologics, nutraceuticals, or cosmetics.

Key Responsibilities

• Assist in the design, development, and review of clinical trial protocols, case report forms (CRFs), informed consent forms (ICFs), and study-related documents.
• Coordinate with Ethics Committees, regulatory authorities (e.g., CDSCO, IECs), and external stakeholders for submissions, approvals, and reporting.
• Support site identification, feasibility studies, and investigator selection.
• Oversee initiation, monitoring, and close-out visits at study sites to ensure compliance with GCP and study protocol.
• Track patient recruitment, enrollment, and data collection activities.
• Maintain trial master files and essential study documentation.
• Coordinate with CROs, labs, and vendors for study-related activities.
• Assist in pharmacovigilance reporting, safety updates, and adverse event documentation.
• Prepare and review clinical study reports, interim reports, and regulatory documents.
• Ensure adherence to SOPs, ICH-GCP, regulatory requirements, and company policies.

Qualifications & Skills

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Good knowledge of ICH-GCP, NDCT Rules (India), and regulatory requirements.
• Strong documentation, and multitasking skills.
• Excellent written and verbal communication skills.
• Proficiency in MS Office (Word, Excel, PowerPoint).

Preferred Attributes

• This job is for Entry level freshers
• Local candidates are preferred (Near by office address).
• Knowledge of pharmacovigilance, BA/BE studies, or medical writing is an advantage.
• Ability to work independently as well as in a team environment.

Job Type: Full-time

Pay: ₹10,000.00 - ₹15,000.00 per month

Benefits:

• Food provided
• Paid sick time

Work Location: In person