Clinical Research Associate

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

• 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.

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..