Experienced Clinical Research Associate, Sponsor Dedicated

Nanosep AB; Reading; On-site; GBP 35,000 - 50,000; Full time

Job summary

Join a leading clinical research organization as an Experienced Clinical Research Associate. You will be instrumental in conducting site monitoring visits, managing project expectations, and ensuring the integrity of study practices, all aimed at driving innovative healthcare solutions. This opportunity promises significant career development in a stable, supportive environment.

Benefits

Career development opportunities

Stable workload and team investment

Use of cutting-edge technologies like iPads

Qualifications

• Experience in independent on-site monitoring.
• Handled multiple protocols across drug indications.

Responsibilities

• Perform site monitoring visits in accordance with GCP and ICH guidelines.
• Manage progress of assigned studies and ensure regulatory compliance.

Skills

Flexible

Strong communication

Written and presentation skills

Education

Life science degree

Job description

Experienced Clinical Research Associate, Sponsor Dedicated

Join to apply for the Experienced Clinical Research Associate, Sponsor Dedicated role at Nanosep AB

Experienced Clinical Research Associate, Sponsor Dedicated

1 day ago Be among the first 25 applicants

Join to apply for the Experienced Clinical Research Associate, Sponsor Dedicated role at Nanosep AB

Our Sponsor Dedicated (cFSP) team is growing and we are looking for aspiring CRAs of all levels, join us on our mission to drive healthcare forward!

What We Offer / USPs

• The chance to work on cutting edge medicines at the forefront of new medicines development
• IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
• We offer genuine career development opportunities for those who want to grow as part of the organization
• We invest in keeping our teams stable, so workload is consistent
• As a CRA you will receive an iPad and use of key developments such as site visit apps, site visit report apps that allow CRAs to do their day job more efficiently
  
  

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement
  
  

Requirements

• You should be life science degree educated
• You have experience of independent on-site monitoring experience
• You've handled multiple protocols and sites across a variety of drug indications
• Flexibility and ability to travel
• Strong communication, written and presentation skills
  
  

Awards

• FORTUNE Magazine's World's Most Admired Companies list for the fourth year in a row - Ranked #1 in Its Category for the Fourth Consecutive Year
• Best AI-based Solution for Healthcare Award in 2023 Artificial Intelligence Breakthrough Awards
  
  

This role is not eligible for UK visa sponsorship

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

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