Clinical Operations Associate

Airvin Skills; Mumbai, Pune District, Bengaluru; Hybrid; INR 450,000 - 700,000; Full time

Job summary

Airvin Skills in Mumbai invites motivated Clinical Operations Associates to support planning, coordination and execution of clinical research activities, ensuring adherence to protocols and regulatory guidelines.

You will coordinate trial activities, maintain essential documentation, assist with informed consent and regulatory processes, ensure ICH-GCP compliance, collaborate with investigators and teams, and help track study progress and reporting.

Qualifications

• Basic knowledge of Clinical Research and Clinical Trial Operations.
• Understanding of ICH-GCP guidelines and clinical trial protocols.
• Knowledge of TMF/ISF documentation.
• Good communication, coordination and organisational skills.
• Proficiency in MS Office, especially Excel and Word.
• Strong attention to detail and problem-solving abilities.

Responsibilities

• Assist in coordinating clinical trial activities and site operations.
• Maintain clinical trial documentation and records.
• Support informed consent and regulatory documentation processes.
• Ensure compliance with ICH-GCP guidelines and study protocols.
• Coordinate with investigators, research teams and other stakeholders.
• Track study progress and assist with clinical trial reporting.

Skills

Clinical Research

ICH-GCP guidelines

TMF/ISF documentation

Communication skills

Organisational skills

Attention to detail

Education

B.Pharm

Pharm.D

M.Pharm

B.Sc. Life Sciences

Biotechnology

Microbiology

Nursing

Tools

MS Office

Excel

Word

Job description

Role Overview:

We are looking for motivated Clinical Operations Associates to support the planning, coordination and execution of clinical research activities while ensuring compliance with clinical trial protocols and regulatory guidelines.

Key Responsibilities:

• Assist in coordinating clinical trial activities and site operations.
• Maintain clinical trial documentation and records.
• Support informed consent and regulatory documentation processes.
• Ensure compliance with ICH-GCP guidelines and study protocols.
• Coordinate with investigators, research teams and other stakeholders.
• Track study progress and assist with clinical trial reporting.

Required Skills:

• Basic knowledge of Clinical Research and Clinical Trial Operations.
• Understanding of ICH-GCP guidelines and clinical trial protocols.
• Knowledge of TMF/ISF documentation.
• Good communication, coordination and organisational skills.
• Proficiency in MS Office, especially Excel and Word.
• Strong attention to detail and problem-solving abilities.

Eligibility:

B.Pharm, Pharm.D, M.Pharm, B.Sc. Life Sciences, Biotechnology, Microbiology, Nursing or other relevant healthcare graduates.