Lambda Therapeutic Research Ltd Jobs hiring for Regional CRA - Clinical Trial
About the Company
We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad - India, with facilities and operations in Mumbai (India), Mehsana (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA with approximate 750 employees located in our facilities across the globe.
Lambda offers full-spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain is executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly.
Delivering the best is accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That's why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.
Job descriptionMinimum 1 Year onsite monitoring at Clinical Trial site required
Send CV to rushabhbshah@lambda-cro.com
Regional CRA for Locations: Mumbai, Delhi, Hyderabad, Bangalore, Chennai, Kolkata, Bhuvaneshwar, Ahmedabad, Pune, Nasik & at Other major cities of India
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 a site (s) for Patient Recruitment, Patient Follow Up, and protocol-related activities.
- Act as a communication link between the 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.
Perks and Benefits
- Medical Insurance (self + 3 Family Member).
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