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Regulatory Coordinator

2 months ago

Chennai, India YRGCARE Full time


Position                    Regulatory Coordinator (backup)

Vacancy                    1

Location                   Chennai               

Reports to                COO

Apply by                   September 30, 2024

 

Salary (per annum) - Commensurate with skills and experience.

 

About YRGCARE


Established in 1993, YRGCARE is a premier non-government organization providing comprehensive HIV services in India with the objective of providing prevention, care, support, and treatment services for people living with HIV/AIDS, to prevent new infections, and ensure that patients and their families are treated with dignity, for more details kindly visit to our website      

About Job


We are looking for an enthusiastic individual with at least 2 years’ experience in clinical research regulatory affairs. In this capacity they will primarily support the regulatory coordinator and their responsibilities include:
  • Performs study-specific regulatory and safety reporting processes across multiple studies in accordance to appropriate regulations and Standard Operating Procedures (SOPs)
  • Submits all necessary documents to the Institutional Review Board/ Ethical Committee for ethical review, notification and approvals of the Study Protocol, Amendments to protocol, Informed Consent forms, Questionnaires, Clarification memos, Study Product Investigational Brochures, Safety memos, Educational Materials etc.  
  • Performs quality assurance of all relevant documents to the IRB prior to submission for approval (study specific Informed Consent forms etc.)
  • Coordinates with translation services related to the Informed Consent forms.
  • Maintains the Investigator Site File (ISF) for all ongoing studies. 
  • Maintains documentation in accordance with established protocols and required preparatory work concerning the projects. 
  • Submit safety reports, safety memos and package Inserts from sponsors to the IRB on a timely basis 
  • Assist physicians and nurses in reporting of Expedited Adverse events/Serious Adverse Events to the Sponsors and Regulatory authorities

Essential Criteria:

  • A first or second degree in biomedical sciences/bioethics.
  • CEFR level C1/C2 proficiency in English. 
  • HSP certification and Good Clinical Practice certification.
  • 2 years’ work experience – may be relaxed to one year one experience if the candidate is uniquely suited for the role.
  • Ability to work independently and as a team.
  • Ability to meet time-sensitive deadlines in a high-pressure environment.

Desirable criteria

  • CEFR C1/C2 proficiency in Tamil.
  • CEFR C1/C2 proficiency in Telugu.
  • Awareness of NIH/DAIDS related research studies.
  • Awareness of national regulatory requirements for ethical conduct of clinical trials.
  • Able and willing to learn and teach in culturally appropriate manner

      Equal Opportunity Employer:

 

YRGCARE is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Join us in making a significant impact through innovative interventions, supporting our mission to improve health outcomes for vulnerable populations. Be a part of our mission to innovate and make a significant impact in viral infections research.