Site Solutions Executive (PRI)

ConfidentialIndia

10 days ago

Job description

Premier Research is looking for a Site Solutions Executive (PRI) 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.

Location : Mumbai

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.

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.

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

Skills Required

GCP guidelines, Clinical trial activities, Patient-awareness training

Create a job alert for this search

Solution • India

Related jobs

Promoted

Senior Site Reliability Engineer- ELK Expert

iVedha Inc.Nagpur, IN

Senior Site Reliability Engineer (SRE) – ELK Expert | Platform Engineering Practice.Must be available to work in the EST (US / Canada) Time Zone. Are you a Senior Site Reliability Engineer (SRE) with ...Show moreLast updated: 30+ days ago

Promoted

Site Reliability Engineer

CapgeminiNagpur, IN

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues...Show moreLast updated: 16 days ago

Promoted

Operations Executive

HINDCO Consulting ServicesNagpur, IN

Manage day-to-day operations of the business related to specific task and business function assigned.Collaborating with various teams to facilitate seamless communication and operational alignment....Show moreLast updated: 7 days ago

Promoted

Site Reliability Engineer

CitNOW GroupNagpur, IN

Founded in 2008, CitNOW is an innovative, enterprise-level software product suite that allows automotive dealerships globally to sell more vehicles and parts more profitably.CitNOW’s app-based plat...Show moreLast updated: 6 days ago

Promoted

Senior Site Reliability Engineer

IntraEdgeNagpur, IN

Strong leadership and people management skills.Exceptional technical proficiency in Pearson's technology stack.Strategic thinking with a focus on long-term operational excellence.Champion operation...Show moreLast updated: 19 days ago

Promoted

Consulting Systems Engineer

World Wide TechnologyNagpur, IN

Pune or Bangalore (50% travel).As a Presales Consultant / Consulting Systems Engineer (CSE), you will be partnering with Client Executives / Client and Account Managers to provide the technical Pre-S...Show moreLast updated: 7 days ago

Promoted

Polarion ALM Expert – Process Implementation & Support

Hexad Infosoft INNagpur, IN

Polarion ALM Expert – Process Implementation & Support.R&D process digitalization project.The role involves implementing, configuring, and optimizing. The expert will collaborate with global stakeho...Show moreLast updated: 3 days ago

Promoted

Site Reliability Engineer (SRE) – Infrastructure & Automation

InstaServiceNagpur, IN

InstaService is revolutionizing the home services industry through AI-driven technology, connecting customers with trusted professionals instantly. We’re growing fast across 23+ states and expanding...Show moreLast updated: 5 days ago

Promoted

Advanced Solutions Engineer

Chargebeenagpur, maharashtra, in

Chargebee is the leading Revenue Growth Management (RGM) platform for subscription businesses.Thousands of companies at every stage of development — from startups to enterprises — use Chargebee to ...Show moreLast updated: 7 days ago

Promoted

Senior Site Reliability Engineer

Nebula Tech Solutionsnagpur, maharashtra, in

SRE team supporting mission-critical applications for our.We’re now looking for engineers who can go beyond operations — those who can. Enhance application reliability through code.Add or modify cod...Show moreLast updated: 7 days ago

Promoted

Business Development Lead

Thalamus AINagpur, IN

Location : Remote (India-based candidates working US hours).Thalamus AI is a prompt-based, multi-agent platform built for enterprises to streamline response management for RFPs, bids, questionnaires...Show moreLast updated: 30+ days ago

Promoted

Reltio Lead / Architect

Mastech DigitalNagpur, IN

Chennai / Bangalore / Hyderabad / Noida / Remote with quarterly visit.LPA (Depending on level of expertise).Immediate joiner / Currently serving notice / Notice is less than 60 days.We are looking for a hands...Show moreLast updated: 27 days ago

Promoted

Site Reliability Engineer

CodeKarmanagpur, maharashtra, in

Site Reliability Engineer (Multi-Cloud Deployments).CodeKarma is redefining how engineering teams understand and evolve complex systems — bringing production context directly into the developer’s w...Show moreLast updated: 27 days ago

Promoted

business developement executive ( Remote )

Counsel Indianagpur, maharashtra, in

Remote

The candidate for this position will excel at creating and closing new opportunities.By using a consultative approach to selling, this person will use their expertise to identify and qualify leads,...Show moreLast updated: 15 days ago

Promoted

Solution Specialist

World Wide TechnologyNagpur, IN

Solution Specialists lead several of the pre-sales processes for qualified services opportunities.WWT’s Sales organization is responsible for creating and qualifying business opportunities.The Solu...Show moreLast updated: 30+ days ago

Promoted

SDE 3

Prosperr.ionagpur, maharashtra, in

As a pioneering fintech SaaS platform, we empower employees to maximize their in-hand salaries and enable businesses to design smarter, compliant, and efficient tax strategies.Through cutting-edge ...Show moreLast updated: 30+ days ago

Promoted

Solutions Advisory Executive

Searce IncRepublic Of India, IN

Solutions Consulting | Executive.Modern tech solutions advisory & 'futurify' consulting as a Searce P&L leader and a fds (‘forward deployed solver’) with revenue accountability from net-new account...Show moreLast updated: 28 days ago

Promoted

Senior Site Reliability Engineer (SRE) – Datadog Observability

Jade Globalnagpur, maharashtra, in

Senior Site Reliability Engineer (SRE) – Datadog Observability.SRE and Infrastructure Operations with minimum 3.Hyderabad preferable but open for Pune and remote. Site Reliability Engineer (SRE).SRE...Show moreLast updated: 7 days ago