Site Solutions Executive (Calicut)

Premier Research is looking for a Site Solutions Executive (Calicut) 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; alsomaintaining 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
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