Premier Research is looking for a Site Solutions Executive (PRI) to join our India Operations team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- Your ideas influence the way we work, and your voice matters here.
- As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Location: Nagpur (Office based)
This is a contract position with a duration of 1 year.
What You'll Be Doing
- Coordinates and facilitates all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations;
- Supports Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators,
- Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator
- Maintaining clinical trial-related documents at site including Trial Master File.
- Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained.
- Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator
- Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner
- Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment
- Responsible for notifying Sponsor / CRO representatives of external audits/ inspections by the sponsor and regulatory authorities respectively.
What We Are Looking For
- Bachelor's or Master's degree in a clinical or related field, or a medical, dental, or nursing qualification.
- Good oral and written communication skills in English, Marathi and Hindi
- 1 year of relevant experience as a Clinical Research Coordinator.
- Attention to detail and documentation and conscious of the importance of time and data accuracy in the clinical trial context
