Regulatory Coordinator

6 days ago

Chetput Chennai Tamil Nadu, India YRGCARE Full time

**Position : Regulatory Coordinator (backup)**

**Vacancy : 1**

**Location : Chennai**

**Reports to: COO**

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

**About YRGCARE**

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.
- 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.

Pay: ₹35,000.00 - ₹40,000.00 per month

Work Location: In person

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