Senior CRA - IQVIA Biotech

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

Job summary

IQVIA Biotech is seeking an experienced On-site Clinical Monitor to oversee oncology studies, conduct site visits, and ensure protocol and regulatory compliance. You will train site staff, manage recruitment plans, and liaise with the study team to drive project success.

Applicants should have 3–4 years of on-site monitoring experience, strong GCP/ICH knowledge, and proficiency in MS Office; fluent English is required. This role is based in the UK and involves extensive site interactions.

Qualifications

• Minimum 3–4 years of on-site monitoring experience.
• Experience monitoring Oncology studies is a must.
• Bachelor's Degree in scientific discipline or health care preferred.
• GCP/ICH regulatory knowledge.
• Written and verbal communication in English.

Responsibilities

• Perform site monitoring visits (start-up, initiation, monitoring and close-out) per scope and GCP/ICH.
• Coordinate with sites to support recruitment planning and predictability.
• Train site staff on protocol and study procedures; maintain regular communication.
• Assess site conduct for protocol adherence and regulatory compliance; escalate issues.
• Track regulatory submissions, recruitment, CRFs, data queries; support start-up as needed.
• Ensure TMF ISF filing and document control per regulatory requirements.
• Prepare site visit reports and follow-up communications; maintain study documentation.
• Collaborate with study team for project execution and issue resolution.
• Possibly support recruitment plans and site budget activities as applicable.

Skills

On-site monitoring

Oncology studies

GCP/ICH knowledge

English fluency

Project coordination

Time management

Financial management

MS Office

Communication skills

Education

Bachelor's degree in scientific discipline

Tools

Microsoft Office Suite

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.

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., 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 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.