Emmes Group, a leader in clinical research, is at the forefront of transforming medical discovery, making breakthroughs in areas like cell and gene therapy, vaccines, ophthalmology, neuroscience, and more. With over 47 years of experience, Emmes partners with public and private sectors to bring medical advancements closer to patients worldwide. As part of its continued growth, Emmes Group is hiring for two key positions in Bengaluru: In-House Clinical Research Associate (CRA) and Clinical Research Associate II.

1. In-House Clinical Research Associate

The In-House CRA at Emmes Group plays a critical role in the management and monitoring of clinical trials. Reporting to the project site management staff, key responsibilities include:

• Site Monitoring: Assist in the management of clinical study sites, ensuring trials comply with protocol and regulatory requirements.
• Essential Document Management: Track and maintain essential documents, ensuring completeness, accuracy, and regulatory compliance.
• Data Management: Update clinical trial management systems (CTMS), track trial progress, and assist with audit preparation.
• Regulatory Submissions: Submit IRB/EC applications and assist with feasibility and site activation.
• Training and Support: Conduct training for site staff and assist in the resolution of issues after site visits.
• Site Recruitment: Assist with recruitment oversight and monitor screening logs.

Qualifications for In-House CRA

The ideal candidate for the In-House CRA role should possess:

• A Bachelor’s degree in a scientific discipline or equivalent experience.
• Previous clinical research experience (CTA, in-house CRA, study coordinator) is preferred.
• Proficiency in MS Office Suite and strong organizational skills.
• High attention to detail and ability to work on multiple projects with critical thinking.
• Excellent communication skills (oral and written).

Skills Required for In-House CRA

• Proficient in MS Office Suite and clinical research software.
• Strong organizational, interpersonal, and communication skills.
• Ability to prioritize tasks, solve problems, and think critically.
• Self-starter who works well with minimal oversight and in a collaborative team setting.
• Knowledge of Good Clinical Practices (GCP) and country-specific regulatory requirements.

2. Clinical Research Associate II

The Clinical Research Associate II (CRA II) is responsible for both remote and on-site monitoring of clinical study sites. The key responsibilities include:

• Site Visits: Conduct monitoring visits (e.g., qualification, initiation, routine, and closeout visits) to ensure regulatory compliance.
• Source Document Review: Verify source documents and ensure that the study is conducted per the protocol and regulatory requirements.
• Training: Provide training to site staff on GCP and study protocols.
• Monitoring Compliance: Ensure sites meet GCP standards and other regulatory requirements.
• Action Item Resolution: Follow up on action items post-visit and provide guidance on study-related issues.
• Regulatory Compliance: Assist with regulatory submissions and ensure compliance with country-specific regulations.

Qualifications for Clinical Research Associate II

For the CRA II role, the following qualifications are preferred:

• A Bachelor’s degree in a scientific discipline or equivalent experience.
• At least 1-2 years of relevant clinical monitoring experience (on-site and remote).
• Knowledge of ICH GCP guidelines and local regulations.
• Proficiency in MS Office Suite and clinical research tools.
• Strong attention to detail and organizational skills.

Skills Required for Clinical Research Associate II

• Proficient in clinical research operations, including the interpretation and implementation of country regulations/ICH guidelines.
• Excellent problem-solving, critical thinking, and decision-making abilities.
• Strong communication skills, both oral and written.
• Ability to collaborate and work cross-functionally with a team.
• Highly organized, adaptable, and self-motivated.

Application Link For In House CRA

Application Link For Clinical Research Associate