Clinical Research Associate

Biological E; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Biological E in Hyderabad is seeking a Clinical Research Coordinator with 4+ years of total experience, including 2+ years as a Clinical Research Associate/Monitor. The role requires travel 50–60% and strong knowledge of ICH GCP and CDSCO guidelines.

You will act as liaison between Sponsor and sites, support study tool design, conduct feasibility, site selection visits, monitoring, and documentation in TMF, ensuring regulatory compliance and timely reporting.

Qualifications

• Strong knowledge and skill in applying all applicable clinical research regulatory requirements; i.e., ICH GCP & CDSCO guidelines.
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication skills including good command over English language.
• Strong organizational and problem-solving skills.
• Open for travelling (50 to 60% travel involved)
• Effective time management skills.

Responsibilities

• Act as a communication Link between Sponsor and the site.
• Support in designing study tools, essential clinical documents and processes.
• Perform Site Identification and conduct Feasibility Studies.
• Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
• Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
• Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required.
• Keep a close association with site (s) for: Subject recruitment, Subject follow up, and protocol related activities.
• Maintain accurate and timely sponsor/site correspondence and communication and update the reporting authority on the status.
• Preparation of training material and coordination with study sites for successful conduct of Investigators Meeting.
• Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
• Facilitation and documentation support for Ethics Committee Submission.
• Help clinical team in preparation of Regulatory Binder.
• Maintain updated Site Files and collection of the essential documents, project related documents during the site visits, and maintenance of Trial Master File (TMF).
• eCRF verification as per the project instructions.
• Coordinate and distribute Clinical Study Material to study sites.
• Archival of study documents.

Skills

GCP knowledge

CDSCO guidelines

English communication

Time management

Willingness to travel

Education

B.Pharm

M.Pharm or life sciences masters

Tools

MS Word

MS Excel

PowerPoint

Job description

Department

Clinical Development

Educational Qualifications

B.Pharm / M.Pharm or Masters in life sciences

Experience

Total Experience should be of 4+ years. Should have definitely worked as a full time Clinical Research Coordinator with a minimum of 2+ years of experience and a minimum of 2+ years as a Clinical Research Associate/Monitor.

Desired Candidate Profile

• Strong knowledge and skill in applying all applicable clinical research regulatory requirements; i.e., International Conference on Harmonization (ICH) GCP & CDSCO guidelines.
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication skills including good command over English language.
• Strong organizational and problem-solving skills.
• Open for travelling (50 to 60% of travel involved)
• Effective time management skills

Responsibilities

1. Act as a communication Link between Sponsor and the site.
2. Support in designing study tools, essential clinical documents and processes.
3. Perform Site Identification and conduct Feasibility Studies.
4. Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
5. Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
6. Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required.
7. Keep a close association with site (s) for: Subject recruitment, Subject follow up, and protocol related activities.
8. Maintain accurate and timely sponsor/site correspondence and communication and update the reporting authority on the status.
9. Preparation of training material and coordination with study sites for successful conduct of Investigators Meeting.
10. Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
11. Facilitation and documentation support for Ethics Committee Submission.
12. Help clinical team in preparation of Regulatory Binder.
13. Maintain updated Site Files and collection of the essential documents, project related documents during the site visits, and maintenance of Trial Master File (TMF).
14. eCRF verification as per the project instructions.
15. Coordinate and distribute Clinical Study Material to study sites.
16. Archival of study documents.

Note: This description serves only to give a broad outline of the duties required and may be renewed and amended at periodic intervals by the reporting authority..