Site Solutions Executive

30 Premier Research Group (India) Private Limited; India; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Premier Research is seeking a Site Solutions Executive for our India Operations to coordinate clinical trial activities at the site, ensuring GCP compliance and timely data entry. You will support the PI, manage site documents, and coordinate ethics submissions and patient investigations.

The role requires 4+ years at clinical research sites, strong English communication, and excellent organizational skills.

Qualifications

• Bachelor's or Master's degree in clinical, biological or mathematical sciences or related fields, or medical/dental or nursing degree.
• Minimum 4 years of experience at clinical research sites.
• Excellent oral and written English, plus at least one local Indian language.
• Strong interpersonal, coordination, and organizational skills with problem-solving ability.
• Attention to detail and documentation with data accuracy in clinical trials.
• Awareness of ethical, scientific requirements and patient safety/rights.
• Familiarity with computers and office tools.

Responsibilities

• Coordinate all clinical trial activities at site ensuring GCP compliance and local regulations; support PI and site team.
• Enter data timelinely into CRF/eCRF; maintain Trial Master File and documents.
• Assist at site initiation, monitoring and close-out visits as required.
• Report site performance metrics regularly.
• Coordinate ethics committee submissions and related documentation.
• Schedule patient investigations and ensure availability of IP and lab kits; store IP per protocol.
• Dispense IP under PI supervision and maintain IP accountability and temperature logs.
• Organize lab sample pickups and transcribe source documents as needed.
• Resolve data queries promptly and accurately.
• Maintain regular contact with site monitor regarding enrollment and visits.
• Facilitate communication between investigator and sponsor/CRO; support patient-awareness events at site.
• Assist data collection activities and build a database of potential patients per protocol.
• Identify challenges and plan mitigations with LM/TSM/PI.
• Complete mandated training and SOPs; notify sponsors of audits/inspections.
• Escalate non-compliance to manager; direct feasibility requests to the CS feasibility team.

Skills

English communication

Interpersonal skills

Coordination

Organizational skills

Problem-solving

Attention to detail

Ethical awareness

Computer proficiency

Education

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

Job description

Premier Research is looking for a Site Solutions Executive 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.

ROLE RESPONSIBILITIES:

• 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 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 To create the database of potential patients that can be enrolled into the study as per the protocol.
• To identify any challenges and find out mitigation plan in advance with the support of LM, TSM & PI.
• Responsible to complete all mandated training and ongoing training modules and SOPs.
• Responsible for notifying Sponsor / CRO representatives of external audits/ inspections by the sponsor and regulatory authorities respectively.
• Collaborates with PI to respond to any audit findings and implement approved recommendations.
• Escalate systemic non-compliance and/or misconduct to his /her manager for appropriate follow-up.
• Directs all feasibilities coming to the site to feasibility team at CS.

REQUIREMENTS:

• 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. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

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.