Senior CRA - IQVIA Biotech

IQVIA LLC; Langley; On-site; GBP 45,000 - 65,000; Full time

Job summary

IQVIA Biotech is seeking an experienced on-site Clinical Monitor to conduct monitoring visits for oncology studies in accordance with GCP/ICH guidelines. The role involves site training, document management, and ongoing collaboration with study teams to ensure protocol compliance and data integrity.

We value strong English communication, rigorous time management, and a proactive approach to recruitment planning and issue resolution.

Qualifications

• Minimum 3–4 years of on-site monitoring experience.
• Experience monitoring Oncology studies is required.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent written and verbal communication in English.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per contract scope and regulatory requirements (GCP/ICH).
• Drive and track subject recruitment plans to align with project needs and enhance predictability.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Escalate quality issues and monitor adherence to protocol and regulatory standards.
• Track regulatory submissions, approvals, recruitment, CRF completion and data queries; support start-up as needed.
• Maintain TMF/ISF documentation and site files in compliance with GCP/ICH and local regs.
• Prepare visit reports, follow-up letters, and other required study documentation; liaise with study team.

Skills

On-site monitoring

GCP/ICH knowledge

English communication

Project coordination

Time management

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

• 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.
• Minimum of 3-4 years of experience of on-site monitoring experience
• Experience monitoring Oncology studies is a must
• 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).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• 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.
• 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.