At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Site Solutions Executive join our team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What You'll 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

• Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary; also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the PI

• 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

• 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

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 cultural anchors – Caring Empathy, Empowerment, Aspiration, One Team – mirror the 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.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.