Website:
ykrita.com
Job details:
Company: Ykrita Life Sciences
Location: Bangalore–Mysore belt (initial), with potential pan-India expansion (travel required)
About the Company
Ykrita Life Sciences is an innovative healthcare start-up developing a breakthrough liver regenerative support system. Our technology, designed with usability and mechanical similarities to a hemodialysis machine, aims to treat patients suffering from Acute Liver Failure (ALF) and Acute-on-Chronic Liver Failure (ACLF). We are currently in the pilot phase of clinical trials and are committed to transforming the landscape of critical liver care through cutting-edge medical innovation.
Role Overview
We are seeking a highly motivated and detail-oriented Clinical Trial Coordinator to oversee and manage clinical trials for a novel Class C medical device across multiple hospitals in India. This role is critical to ensuring the smooth execution of clinical studies, regulatory compliance, and coordination across stakeholders.
The ideal candidate will play a central role in trial operations, regulatory submissions, and data integrity while working closely with clinical teams, regulatory bodies, and internal stakeholders.
Key Responsibilities
- Coordinate and manage clinical trial activities across multiple hospital sites
- Liaise with principal investigators, hospital staff, sponsors, and CROs to ensure smooth trial execution
- Develop and maintain trial protocols, informed consent forms, and case report forms in compliance with regulatory standards
- Schedule, track, and monitor trial progress across participating sites
- Act as the primary point of contact between hospitals, sponsors, CROs, and regulatory authorities
- Organize investigator meetings, training sessions, and site initiation visits
- Ensure compliance with CDSCO guidelines, ICMR ethical standards, and Good Clinical Practice (GCP)
- Prepare and submit regulatory documentation to the Central Licensing Authority (CLA) and Institutional Ethics Committees (IECs)
- Coordinate with CDSCO for approvals, amendments, and reporting requirements
- Maintain accurate trial documentation, patient records, and adverse event reports
- Ensure timely submission of progress reports, safety updates, and final study reports
- Conduct site monitoring visits to ensure adherence to protocols and SOPs
- Implement corrective and preventive actions for protocol deviations
- Support audits and inspections by regulatory authorities
Essential Qualifications
- Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field
- Minimum 3–5 years of experience in clinical trial coordination, preferably with medical devices
- Strong understanding of CDSCO Medical Device Rules (2017) and Class C device requirements
- Excellent organizational, communication, and stakeholder management skills
- Ability to manage multiple clinical sites and stakeholders simultaneously
Desired Qualifications
- Certification in Good Clinical Practice (GCP) or clinical research
- Experience working with medical device clinical trials in India
- Familiarity with regulatory submissions and ethics committee processes
- Prior experience in a research-driven or startup healthcare environment (a plus)
What we Offer
- Opportunity to work on pioneering, life-saving medical technology
- Direct involvement in clinical research and regulatory strategy
- A fast-paced, mission-driven startup environment
- A high-impact role with visibility across clinical, regulatory, and product teams
Compensation
Salary will be competitive and commensurate with the candidate’s experience and profile.
Click on Apply to know more.