Clinical Operations Coordinator

Why This Role Matters
The Clinical Research Coordinator (CRC) plays a crucial role in ensuring the smooth execution of clinical trials at the site level. Clinical research depends heavily on proper documentation, ethical compliance, patient coordination, and adherence to regulatory guidelines. This role directly supports investigators in conducting trials that meet international standards such as ICH-GCP and national guidelines like ICMR.
For pharmacy graduates seeking to enter clinical research operations, this position offers structured exposure to real-time trial management, regulatory documentation, and patient interaction. It serves as a strong foundation for building a long-term career in clinical research, regulatory affairs, or clinical project management.

Job Description
SMO Clinical Research (I) Pvt. Ltd is inviting applications for the position of Clinical Research Coordinator (CRC) at its Hyderabad location. The CRC will coordinate site-level clinical trial activities, ensure regulatory compliance, and assist investigators in patient management and documentation processes.
The role involves working closely with sponsors, monitors, ethics committees, and internal site teams to maintain trial quality and compliance. This is an excellent opportunity for B.Pharm and M.Pharm graduates, including freshers, who are looking to establish a structured career in clinical research operations.

Key Features of the Role:
• Hands-on exposure to regulated clinical trial environments.
• Involvement in site management and regulatory compliance.
• Direct interaction with investigators, patients, and sponsors.
• Career pathway toward CRA, Project Coordinator, or Regulatory roles.
• Ideal entry-level opportunity for pharmacy graduates.

Responsibilities
• Coordinate clinical trial activities at the site level.
• Ensure compliance with ICH-GCP and ICMR guidelines.
• Assist investigators in patient recruitment and informed consent processes.
• Maintain essential clinical trial documentation including ISF, source documents, and CRFs.
• Handle ethics committee submissions and regulatory documentation.
• Schedule patient visits and follow-ups.
• Ensure strict protocol adherence and data accuracy.
• Communicate effectively with sponsors, monitors, and internal site teams.

Required Qualifications
• Strong understanding of clinical research processes.
• Knowledge of GCP and ICMR guidelines.
• Good communication and documentation skills.
• Ability to maintain accuracy and attention to detail.

Educational Requirements:
• B.Pharm or M.Pharm (Priority given).

Experience and Skills:
• Freshers are eligible to apply.
• Candidates with prior CRC or clinical trial experience preferred.
• Good verbal and written communication skills.
• Language proficiency in English, Telugu, and Hindi.
• Strong organizational and coordination skills.

Salary Insights
Compensation will be aligned with industry standards for entry-level CRC positions. Candidates with prior experience may receive competitive salary consideration. This role provides strong career growth potential within clinical operations.

Company Overview
SMO Clinical Research (I) Pvt. Ltd is a Site Management Organization (SMO) supporting regulated clinical trials across therapeutic areas. The company focuses on maintaining high-quality standards in site management, regulatory compliance, and patient safety in accordance with national and international clinical research guidelines.

FAQs
1. Can freshers apply for this CRC position?
Yes, fresh B.Pharm and M.Pharm graduates are eligible to apply.
2. Is prior clinical research experience mandatory?
No, but candidates with CRC or trial experience will be preferred.
3. What career growth opportunities are available?
The role provides a pathway toward Clinical Research Associate (CRA), Project Coordinator, or Regulatory Affairs positions.
4. Are language skills important for this role?
Yes, proficiency in English, Telugu, and Hindi is required for patient and stakeholder communication.

Application Tips
• Highlight your academic knowledge of GCP and ICMR guidelines.
• Mention any internships, hospital training, or research exposure.
• Emphasize communication skills and documentation accuracy.
• Showcase your interest in long-term clinical research careers.