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