1,295 Clinical Research Teams jobs in India

Job Title:

Clinical Research Associate

Business Unit:

Clinical Research

Location:

Hyderabad

At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

Job Requirements

Educational Qualification

Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research

Experience

Relevant experience of 1-5 years minimum in the field of Clinical Research.

Additional Skills:

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

• Conduct site initiation, interim monitoring, and close-out visits.
• Verify accuracy and completeness of clinical trial data through source document review.
• Ensure compliance with study protocols, GCP, and regulatory requirements.
• Manage and maintain essential study documents.
• Serve as the primary point of contact for assigned investigational sites.
• Train and support site personnel on study procedures.
• Monitor patient recruitment and retention efforts.
• Report and track adverse events and deviations.
• Collaborate with project management and other study team members.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Previous experience as a Clinical Research Associate (CRA) or in a similar clinical trial role.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience with electronic data capture (EDC) systems.
• Strong organizational and time management skills.
• Excellent written and verbal communication skills.
• Ability to travel to clinical sites as required.
• Proficiency in Microsoft Office Suite.

• Conduct site initiation, monitoring, and close-out visits for clinical trials according to study protocols and Standard Operating Procedures (SOPs).
• Ensure adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols.
• Verify the accuracy, completeness, and integrity of clinical data through source document verification.
• Manage investigational product accountability and ensure proper storage and handling.
• Train and support site personnel on study-specific procedures, regulatory requirements, and data collection.
• Identify and report adverse events and serious adverse events promptly according to protocol and regulatory guidelines.
• Communicate effectively with investigators, study coordinators, and other site personnel to resolve data discrepancies and address protocol deviations.
• Prepare and submit monitoring reports and follow up on action items identified during site visits.
• Ensure timely collection of essential documents and regulatory binders.
• Collaborate with internal study teams, including project managers, data managers, and medical monitors.
• Participate in investigator meetings and training sessions.
• Contribute to the continuous improvement of clinical trial processes and quality standards.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
• In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
• Proven ability to conduct site monitoring visits effectively and efficiently.
• Excellent understanding of clinical trial procedures, including informed consent, data collection, and adverse event reporting.
• Strong analytical, problem-solving, and critical-thinking skills.
• Exceptional attention to detail and organizational skills.
• Excellent written and verbal communication skills, with the ability to build rapport with site staff.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical trial sites as required (approximately 50-70% travel).
• A proactive and results-oriented approach to work.

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with protocol and regulatory requirements.
• Ensure adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and study protocols.
• Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
• Monitor patient safety and report adverse events as per regulatory guidelines.
• Train and support site personnel on study procedures and documentation.
• Maintain effective communication with investigators, study coordinators, and other site staff.
• Prepare and submit site monitoring reports in a timely manner.
• Manage investigational product accountability at study sites.
• Ensure timely resolution of data queries and action items identified during monitoring visits.
• Stay updated on relevant therapeutic areas, drug development processes, and regulatory guidelines.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree is a plus.
• Minimum of 3-5 years of experience as a Clinical Research Associate.
• Thorough understanding of GCP, ICH guidelines, and FDA regulations.
• Experience in monitoring oncology clinical trials is highly preferred.
• Excellent written and verbal communication skills.
• Strong organizational and time management abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to sites as needed (though the role is primarily remote).
• Detail-oriented with a strong commitment to quality and patient safety.
• Self-motivated and able to work independently in a remote setting.