Attend and facilitate Investigators’ Meeting.
Training of Investigators on Protocol and other applicable regulatory guidelines.
Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) in accordance with the protocol and other applicable regulatory guidelines.
Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities
Ensure compliance of all study-related requirements and its documents/data.
Coordinate and distribute Clinical Study Materials to study sites
Ensure calibration of all equipment to be used for the study.
Act as a communication Link between LTR team and the site
Maintain accurate and timely sponsor/site correspondence and communication
Maintain updated Site Files and collection of project related documents during the site visits and maintain Site Master file
CRF retrieval/ e-CRF review as per the project management plan and project manager instructions
Archival of study documents in a timely manner at sites or at third party archival facility as per prevailing SOPs and project management plan.
Any other responsibilities as assigned by the Supervisor/HOD/Management.
Lambda Therapeutic Research, founded in 1999, is a leading full-service Global Clinical Research Organisation (CRO) headquartered in Ahmedabad, India, with facilities and activities in Mehsana, India, Warsaw, Poland, London, UK, Toronto, Canada, Pittsburgh, USA, and Las Vegas, USA. Lambda offers full-service clinical research to the global innovator, biotech, and generic pharmaceutical industries. Our experienced team of 1500+ specialists uses cutting-edge technology and new solutions to provide a broad range of clinical trial solutions, from preclinical research to post-marketing studies, with a commitment to quality. Over the course of 22 years, we have received various awards, including the title of 'Best Indian CRO' by Frost & Sullivan (USA) and the coveted title of 'Great Indian Workplace' by UBS Transformance.