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Regional CRA

 Lambda Therapeutic Research Limited

  • 2 - 7 years
  • Pune
  • Applicants: 0
  • Views: 50
  • Posted: 19 02 2020
  • Full Time

Job Details

Experience: 2 - 7 years

Qualification: B.Sc(Any)

Salary Offered: 3 - 5 Lakhs Annually

Functional Area: Pharmaceutical / Biotechnology

Industry: Bio Technology / Life Sciences

Role: Clinical Research Scientist

Job Location: Pune

Gender: Any Gender

Number of Vacancy: 1

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.

Skills Required

cra
Project Management
site selection

Key Requirements

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.

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Company Logo

Email: bd@lambda-cro.com

Contact Person: HR

Web: LambdaTherapeuticResearchLimited

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