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.
- 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.
- 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).
- 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
Salary
Hourly based
Location
KA , India KA, India
KA , India KA, India
