Premier Research
Website:
premier-research.com
Job details:
Premier Research is looking for a Site Solutions Executive - Srinagar, India 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.
What You'll Be Doing
This is an on-site role based at one of our sites in Srinagar, India
- 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,
- Reviews the site processes, identifies gaps and supports roll-out of site processes.
- The following key functions are required routinely:
- 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.
- Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections.
- Reporting site-performance metrics at pre-determined frequency.
- 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
- Organizing and coordinating laboratory sample pick-ups and reporting
- Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment
- Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/dispensing
- Facilitating cordial and timely communication between investigator and sponsor/CRO
- Supporting patient-awareness, training or other events at site or in the neighborhood
- Supporting data collection activity at site including but not limited to feasibilities, epidemiological data
- To create the database of potential patients that can be enrolled into the study as per the protocol
What We Are Looking For
- A bachelor’s or master’s degree in clinical, biological or mathematical sciences or related fields, or a medical or dental degree or a nursing qualification; Exceptions to this would require a minimum of 4 years of experience of working at clinical research sites.
- Good oral and written communication skills in English and at least one local Indian language
- Excellent interpersonal skills
- Good coordination and organizational skills and also problem-solving and analytical skills
- Attention to detail and documentation and conscious of the importance of time and data accuracy in the clinical trial context
Click on Apply to know more.
