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 https://www.yrgcare.org/
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.
Job Type: Full-time
Pay: ₹35,000.00 - ₹40,000.00 per month
Work Location: In person