Lambda Therapeutic Research
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.
Job Title: Clinical Research Associate
Salary: INR 3,00,000 – 8,00,000 P.A.
Job Description:
RESPONSIBILITIES:
- 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: Patient Recruitment, Patient Follow Up, and protocol related activities.
- Act as a communication Link between Sponsor and the site.
- Maintain accurate and timely sponsor/site correspondence and communication.
- Attend Investigators Meeting.
- Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
- Ethics Committee Submission
- Help in preparation of Regulatory Binder.
- Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File.
- CRF retrieval as per the project instructions.
- Coordinate and distribute Clinical Study Material to study sites.
- Archival of study documents.
Qualifications: Education:UG -B.Pharma – Pharmacy
