CRA II - IQVIA Biotech

IQVIA; Greater London; In loco; GBP 32.000 - 52.000; Tempo pieno

Descrizione del lavoro

IQVIA Biotech in the United Kingdom seeks a site monitor with 1–2 years of on-site monitoring experience, especially in oncology trials. You will ensure quality, compliance with GCP/ICH, and effective collaboration with clinical sites.

Your role includes coordinating site training, tracking recruitment, and maintaining TMF/ISF documentation, with potential involvement in start-up and contract-based financial tasks. English proficiency is essential.

Competenze

• 1–2 years of on-site monitoring experience.
• Experience monitoring Oncology studies.
• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted.
• Basic knowledge of, and skill in applying, GCP/ICH guidelines.
• Written and verbal communication skills including good command of English.

Mansioni

• Perform site monitoring visits in accordance with scope and GCP/ICH guidelines.
• Work with sites to adapt, drive and track subject recruitment plan.
• Administer protocol and related study training to sites and maintain regular communications.
• Evaluate the quality and integrity of site practices and escalate issues as appropriate.
• Manage progress of studies: regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
• Ensure site documents are filed in TMF and ISF maintained per regulatory requirements.
• Create and maintain documentation on site management and visit findings.
• Collaborate with study team members for project execution support.
• May support development of site recruitment plans per site.
• May support site financial management according to contract.

Conoscenze

On-site monitoring

GCP/ICH knowledge

English communication

Formazione

Bachelor's degree in scientific discipline or healthcare

Descrizione del lavoro

Join IQVIA Biotech - Where Innovation Meets Impact

At IQVIA Biotech, we specialize in partnering with smaller biotech and emerging biopharma companies, creating a uniquely dynamic and fast-paced environment. Here, you won't just be part of the process—you'll be at the forefront of it. You'll gain early insights into groundbreaking therapies and novel diseases, often before they reach the broader scientific community.

If you're passionate about innovation and eager to make a real difference in the world of biotech, this is your opportunity to thrive.

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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.

Qualifications

• Minimum 1-2 years of experience of on-site monitoring experience.
• Experience monitoring Oncology studies required.
• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Written and verbal communication skills including good command of English language.

Please note -this position is not eligible for visa sponsorship; full UK right to work is required

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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.