Senior Clinical Research Associate

Dr. APJ Abdul Kalam Technical University (affiliated institutes); Kanpur; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Dr. APJ Abdul Kalam Technical University (AKTU) in Kanpur invites applications for a Senior Clinical Research Associate.

This full-time, on-site role oversees planning, initiation, and monitoring of clinical research projects and trials, ensuring adherence to approved protocols, regulatory requirements, and institutional guidelines. The position involves coordinating clinical operations, supporting investigators, verifying data accuracy, preparing ethics and regulatory reports, conducting site

Qualifications

• Thorough understanding of study protocol design, review, and implementation.
• Experience leading clinical research activities and CRA roles.
• Expertise in clinical trials management including site coordination and monitoring.
• Skilled in research methods, data collection and analysis in clinical/biomedical settings.
• Strong capabilities in clinical operations, documentation, regulatory compliance, and stakeholder coordination.
• Advanced degree (MSc/PhD) in life sciences, pharmacy, medicine, or related field preferred.
• Solid knowledge of GCP, ethical guidelines, and applicable regulations.
• Excellent organizational, analytical, and communication skills; ability to mentor staff.

Responsibilities

• Coordinate clinical operations, support investigators and study teams.
• Oversee planning, initiation, and monitoring of clinical research projects and trials.
• Ensure activities follow approved protocols, regulatory requirements, and guidelines.
• Conduct site visits, train junior research staff, and manage timelines.
• Verify data accuracy and prepare documentation and reports for ethics committees and regulators.
• Collaborate with cross-functional teams to promote high standards of research quality and safety.

Skills

Protocol design

Study oversight

Clinical Trials management

Site coordination

Data analysis

Regulatory compliance

GCP knowledge

Education

Advanced degree (MSc/PhD)

Job description

Company Description

Dr. APJ Abdul Kalam Technical University (AKTU) is a leading public technical university in Uttar Pradesh, India, with a wide network of affiliated institutes offering engineering, technology, pharmacy, and management programs. The affiliated institutes in Kanpur focus on high-quality technical education, applied research, and industry collaboration. Faculty, researchers, and staff work together to advance scientific innovation and improve societal outcomes through research-driven initiatives. The university environment encourages ethical practices, interdisciplinary projects, and professional growth for research professionals.

Role Description

The Senior Clinical Research Associate role is a full-time, on-site position based at affiliated institutes of Dr. APJ Abdul Kalam Technical University in Kanpur. The individual will oversee the planning, initiation, and monitoring of clinical research projects and clinical trials, ensuring that study activities follow approved protocols, regulatory requirements, and institutional guidelines. Day-to-day responsibilities include coordinating clinical operations, supporting investigators and study teams, verifying data accuracy and completeness, and preparing documentation and reports for ethics committees and regulatory bodies. The role involves conducting site visits, training junior research staff, managing study timelines, and contributing to the development and refinement of clinical research processes. The Senior Clinical Research Associate will also collaborate with cross-functional teams to promote high standards of research quality, participant safety, and compliance.

Qualifications

• Candidates should possess strong knowledge of study Protocol design, review, and implementation.


• Candidates should possess experience working as Clinical Research Associates and leading clinical research activities.


• Candidates should possess expertise in Clinical Trials management, including site coordination and monitoring.


• Candidates should possess skills in Research methods, data collection, and analysis in a clinical or biomedical setting.


• Candidates should possess capabilities in Clinical Operations, including documentation, regulatory compliance, and stakeholder coordination.


• Advanced degree (Master’s or Ph.D.) in life sciences, pharmacy, medicine, or a related field is preferred.


• Thorough understanding of Good Clinical Practice (GCP), ethical guidelines, and relevant national/international regulations.


• Strong organizational, analytical, and communication skills, with the ability to mentor junior staff and work in multidisciplinary teams.


• Prior experience in academic or hospital-based research settings will be an advantage.