Site Solutions Executive- Mysuru

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional **Site Solution Executive** to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

**What you will be doing**:
To coordinate and facilitate all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations ;
- To support 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
- To fulfil the duties and responsibilities stated above, the SSE will perform the following functions: ― 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.
- To coordinate and support clinical trial activities related to a study or studies at a site or sites
- To support partnering and growth opportunities within the site(s) or location of the sites

― 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

― Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person.

― Assisting in timely resolution of data queries

― 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

**Why **ch**oose** Premier Research?**
- Why Choose Premier Research?
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.