Site Solutions Executive Level 2

30 Premier Research Group (India) Private Limited; India; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Premier Research in India is seeking a Site Solutions Executive Level 2 to support clinical trial activities at our India Operations team. The role involves coordinating site activities, ensuring protocol adherence, assisting PI and site teams, and maintaining trial documentation and data entry in CRF/eCRF systems.

You will contribute to site initiation, monitoring, and close-out visits, help prepare site performance metrics, and uphold patient-safety and regulatory standards while collaborating

Qualifications

• Bachelor’s or Master’s degree in clinical, biological or related sciences or medical/dental/nursing.
• 4+ years of experience at clinical research sites.
• Strong English and local language communication skills.
• Excellent interpersonal, coordination and organizational skills.
• Strong attention to detail and data accuracy in trials.

Responsibilities

• Coordinate and facilitate all clinical trial activities at site ensuring protocol adherence and GCP compliance.
• Support PI and site team to meet sponsor/regulator criteria.
• Review site processes, identify gaps and support rollout of improvements.
• Perform timely data entry of CRF/eCRF in consultation with PI/Investigator; maintain Trial Master File.
• Prepare for site initiation, monitoring, and close-out visits and QA sponsor inspections.
• Report site performance metrics at predetermined frequency.

Skills

English communication

Interpersonal skills

Coordination

Attention to detail

Analytical skills

Problem solving

Education

Bachelor’s or Master’s in clinical/biological/mathematical sciences or medical/dental/nursing

Tools

MS Office

eCRF systems

Job description

Premier Research is looking for a Site Solutions Executive Level 2 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:

• 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.
• 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.

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
• Conscious of ethical and scientific requirements and of patient-safety and patient-rights in the clinical trial context
• Familiarity with computer usage and office communication tools.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. 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.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.